>

CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 1 of 55
Effects) for Surgical

Purpose
This document provides a list of complaint reasons and IMDRF Codes for Annexes A, E and F by product category to assist the user
in selecting the appropriate codes for Surgical product complaints. Refer to http://www.imdrf.org/working-groups/adverse-event-
terminology for additional IMDRF codes.
Note: For reportable events, evaluate Annex E and F codes for appropriate selection.

I. CATARACT
CATARACT Annex A Annex E Annex F
Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
An adverse event (e.g. patient harm) Health effect appears to have occurred but
appears to have occurred, but there does there is not yet enough information There is not yet enough
not appear to have been a problem with available to classify the clinical signs, information available to classify
Adverse Event A24 the device or the way it was used. E2401 symptoms and conditions. F24 the health impact.
An adverse event (e.g. patient harm) A local or general reaction of an organism
appears to have occurred, but there does following contact with a specific allergen to A mild injury, illness or
not appear to have been a problem with which it has been previously exposed and to impairment which can be treated
Allergic Reaction A24 the device or the way it was used. E0402 which it has become sensitized. F11 with minimal or no intervention.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with Decreased ability to see to a degree that impairment which can be treated
Astigmatism A24 the device or the way it was used. E0839 requires corrective measures F11 with minimal or no intervention.
Problem associated with an inherent device No patient involvement or, no observable
Axis Mark characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Faint/Missing A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with Decreased ability to see to a degree that impairment which can be treated
BCVA Loss A24 the device or the way it was used. E0839 requires corrective measures F11 with minimal or no intervention.
Problem associated with an undesired No patient involvement or, no observable
material change in shape or property clinical symptoms or a change in symptoms No apparent harm occurred in
Bent Tip A0406 caused by external forces. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with undesired damage No patient involvement or, no observable
or breakage of those materials used in the clinical symptoms or a change in symptoms No apparent harm occurred in
Break / Crack A0401 device construction. E2403 is identified in the patient. F26 relation to the adverse event.

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 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 2 of 55
Effects) for Surgical

CATARACT Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Bubbles A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm)
appears to have occurred, but there does The clinical signs, symptoms and conditions A mild injury, illness or
not appear to have been a problem with are not adequately described by any other impairment which can be treated
Calcification A24 the device or the way it was used. E2402 term. F11 with minimal or no intervention.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Calculator Error A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with impairment which can be treated
Capsule Damage A24 the device or the way it was used. E0801 A tear in the capsular bag housing the lens. F11 with minimal or no intervention.
Problem related to an obstruction or
blockage within the device component (e.g. No patient involvement or, no observable
tube, opening, pipe) that results in clinical symptoms or a change in symptoms No apparent harm occurred in
Clogged A1409 restriction of flow (including blood clotting). E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
Color Perception not appear to have been a problem with An interference to normal eyesight without impairment which can be treated
Altered A24 the device or the way it was used. E0838 necessarily affecting visual acuity. F11 with minimal or no intervention.
Problem associated with the separation of No patient involvement or, no observable
Component the device from its physical construct, clinical symptoms or a change in symptoms No apparent harm occurred in
Detachment A0501 integrity, or chassis. E2403 is identified in the patient. F26 relation to the adverse event.
No patient involvement or, no observable
A device component(s) found to be missing clinical symptoms or a change in symptoms No apparent harm occurred in
Component Missing A020602 when delivered to the user facility. E2403 is identified in the patient. F26 relation to the adverse event.
Problems associated with mechanical No patient involvement or, no observable
Component Not actions or defects, including moving parts clinical symptoms or a change in symptoms No apparent harm occurred in
Functioning A05 or subassemblies, etc. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) Inability to maintain corneal integrity; or
appears to have occurred, but there does corneal edema resulting from failure of the A mild injury, illness or
Corneal not appear to have been a problem with corneal endothelium to maintain impairment which can be treated
Decompensation A24 the device or the way it was used. E0806 detumescence. F11 with minimal or no intervention.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 3 of 55
Effects) for Surgical

CATARACT Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with impairment which can be treated
Corneal Edema A24 the device or the way it was used. E0807 Hazy, swollen cornea. F11 with minimal or no intervention.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with impairment which can be treated
Crocodile Shagreen A24 the device or the way it was used. E0807 Hazy, swollen cornea. F11 with minimal or no intervention.
An adverse event (e.g. patient harm)
appears to have occurred, but there does Accumulation of intraretinal fluid and A mild injury, illness or
Cystoid Macular not appear to have been a problem with protein in the macula, which may result in impairment which can be treated
Edema A24 the device or the way it was used. E0830 swelling and decreased central vision. F11 with minimal or no intervention.
Problem associated with undesired damage No patient involvement or, no observable
or breakage of those materials used in the clinical symptoms or a change in symptoms No apparent harm occurred in
Damage - Physical A0401 device construction. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the undesired
introduction of impurities either chemical No patient involvement or, no observable
or microbiological in nature, or of foreign clinical symptoms or a change in symptoms No apparent harm occurred in
Deposits / Residue A1801 matter into or onto the device. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the inability of the No patient involvement or, no observable
Did Not Exit Inserter device to be ejected or discharged from its clinical symptoms or a change in symptoms No apparent harm occurred in
Properly A050301 physical location. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the use of the
device in terms of user experiencing
difficulty in preparing device for use, even if No patient involvement or, no observable
Difficult to Assemble the operation is being performed according clinical symptoms or a change in symptoms No apparent harm occurred in
Shuttle A2201 to labeled instructions for use. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the use of the
device in terms of user experiencing
difficulty in preparing device for use, even if No patient involvement or, no observable
the operation is being performed according clinical symptoms or a change in symptoms No apparent harm occurred in
Difficult to Load A2201 to labeled instructions for use. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the written, No patient involvement or, no observable
printed or graphic material accompanying clinical symptoms or a change in symptoms No apparent harm occurred in
Diopter Mislabeled A2101 or affixed to the device or any of its E2403 is identified in the patient. F26 relation to the adverse event.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 4 of 55
Effects) for Surgical

CATARACT Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
packaging. This includes verbal instructions
relating to identification, technical
description, and usage provided by the
device manufacturers. Problems can include
but are not limited to this material being
unclear, missing, worn out, incorrect or
inaccurate.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with Perception of multiple images from one impairment which can be treated
Diplopia A24 the device or the way it was used. E083903 object. F11 with minimal or no intervention.
Problem associated with an undesired
streak, pattern and/or a noticeable change No patient involvement or, no observable
in color from the rest of the materials used clinical symptoms or a change in symptoms No apparent harm occurred in
Discolored A0407 in the device construction. E2403 is identified in the patient. F26 relation to the adverse event.
Problem with all or part of an implanted or A mild injury, illness or
invasive device moving from its intended impairment which can be treated
Dislocation A010402 location within the body. E2107 Malfunction of a medical implant. F11 with minimal or no intervention.
The report describes a non-specific problem
An adverse event (e.g. patient harm) with the eye(s) or vision. Note: Please use
appears to have occurred, but there does "Appropriate Term / Code Not Available" if A mild injury, illness or
Dissatisfaction with not appear to have been a problem with the report describes a specific problem but impairment which can be treated
Vision A24 the device or the way it was used. E0844 the relevant term does not exist. F11 with minimal or no intervention.
A syndrome characterized by dryness of the
cornea and conjunctiva. It is usually caused
An adverse event (e.g. patient harm) by a deficiency in tear production.
appears to have occurred, but there does Symptoms include a feeling of burning eyes A mild injury, illness or
Dry Eye / Burning / not appear to have been a problem with and a possible foreign body presence in the impairment which can be treated
Itching / Redness A24 the device or the way it was used. E0815 eye. F11 with minimal or no intervention.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with An interference to normal eyesight without impairment which can be treated
Dysphotopsia A24 the device or the way it was used. E0838 necessarily affecting visual acuity. F11 with minimal or no intervention.
An adverse event (e.g. patient harm) Inflammation of the intraocular fluids or A mild injury, illness or
Endophthalmitis A24 appears to have occurred, but there does E0816 tissues usually with microbial organisms. F11 impairment which can be treated

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 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 5 of 55
Effects) for Surgical

CATARACT Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
not appear to have been a problem with with minimal or no intervention.
the device or the way it was used.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Expired Product A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with impairment which can be treated
Fibrin Reaction A24 the device or the way it was used. E0819 Damage to the eye. F11 with minimal or no intervention.
Substances that consist of separate No patient involvement or, no observable
particles that are introduced by the device clinical symptoms or a change in symptoms No apparent harm occurred in
FM / Particulate A030205 during use. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the use of the
device in terms of user experiencing
difficulty to close or to spread out/extend
length of the device, even if the operation is No patient involvement or, no observable
being performed according to labeled clinical symptoms or a change in symptoms No apparent harm occurred in
Folding Issues A051103 instructions for use. E2403 is identified in the patient. F26 relation to the adverse event.
No patient involvement or, no observable
Frost Indicator / Problem associated with shipping damage clinical symptoms or a change in symptoms No apparent harm occurred in
Received Frozen A0207 or problem prior to the use of the device. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
Glare / Halos / not appear to have been a problem with An interference to normal eyesight without impairment which can be treated
Starburst A24 the device or the way it was used. E0838 necessarily affecting visual acuity. F11 with minimal or no intervention.
An adverse event (e.g. patient harm)
appears to have occurred, but there does Increased pressure in the eyeball due to A mild injury, illness or
Glaucoma / Increased not appear to have been a problem with obstruction of the outflow of aqueous impairment which can be treated
IOP A24 the device or the way it was used. E0822 humor. F11 with minimal or no intervention.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with An interference to normal eyesight without impairment which can be treated
Glistenings A24 the device or the way it was used. E0838 necessarily affecting visual acuity. F11 with minimal or no intervention.
Heat Indicator/
Received Overheated A0207 Shipping Damage or Problem E2403 No Clinical Signs, Symptoms or Conditions F27 No Patient Involvement

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 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 6 of 55
Effects) for Surgical

CATARACT Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with Increase of pressure of the intraocular fluid impairment which can be treated
Increased IOP A24 the device or the way it was used. E0827 in the eye. F11 with minimal or no intervention.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with An infection of any part of the eye, impairment which can be treated
Infection A24 the device or the way it was used. E0818 including the eyelid. F11 with minimal or no intervention.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A regionally-limited response to an antigen, A mild injury, illness or
not appear to have been a problem with which may include inflammation, impairment which can be treated
Inflammation A24 the device or the way it was used. E040203 induration, erythema, pruritus or pain. F11 with minimal or no intervention.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with impairment which can be treated
Iris Bleeding / Damage A24 the device or the way it was used. E0819 Damage to the eye. F11 with minimal or no intervention.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with impairment which can be treated
Iritis A24 the device or the way it was used. E0828 Inflammation of the iris. F11 with minimal or no intervention.
Problem associated with the written,
printed or graphic material accompanying
or affixed to the device or any of its
packaging. This includes verbal instructions
relating to identification, technical
description, and usage provided by the
device manufacturers. Problems can include
but are not limited to this material being No patient involvement or, no observable
unclear, missing, worn out, incorrect or clinical symptoms or a change in symptoms No apparent harm occurred in
Labeling Problem A2101 inaccurate. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the escape of a No patient involvement or, no observable
liquid, gas or radiation from the vessel or clinical symptoms or a change in symptoms No apparent harm occurred in
Leak - Air / Fluid A0504 container in which it is housed. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable No apparent harm occurred in
Lens Damage - Haptic A0201 characteristic that is not satisfactory as E2403 clinical symptoms or a change in symptoms F26 relation to the adverse event.

Viewed/Printed: 6 December 2022 7:36:48 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258685 < > Rev 3 >
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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 7 of 55
Effects) for Surgical

CATARACT Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
specified or delivered. is identified in the patient.
Problem associated with an inherent device No patient involvement or, no observable
Lens Damage - Not characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Specified A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Lens Damage - Optic A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Lens Loose in Package A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the inability of the No patient involvement or, no observable
Lens Stuck in Delivery device to be ejected or discharged from its clinical symptoms or a change in symptoms No apparent harm occurred in
Device A050301 physical location. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an undesired No patient involvement or, no observable
material change in physical property, clinical symptoms or a change in symptoms No apparent harm occurred in
Lens Unable to Fold A040603 characterized by failure to fold. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable
Lens Vaulting / CCS / characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Z-Syndrome A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
Inconsistent filling of a device. This
describes a problem which is observed to
vary between overfilling and under filling, No patient involvement or, no observable
and may be intermittent. Use "Overfill" or clinical symptoms or a change in symptoms No apparent harm occurred in
Low / No Fluid in Vial A140304 "Short Fill" if problem is consistent. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Luer Lock Issue A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Miscellaneous A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable
Mushroomed/Bulged characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Tip A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
A device component(s) found to be missing No patient involvement or, no observable No apparent harm occurred in
No Lens in Case A020602 when delivered to the user facility. E2403 clinical symptoms or a change in symptoms F26 relation to the adverse event.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 8 of 55
Effects) for Surgical

CATARACT Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
is identified in the patient.
No patient involvement or, no observable
A device component(s) found to be missing clinical symptoms or a change in symptoms No apparent harm occurred in
No Ring in Container A020602 when delivered to the user facility. E2403 is identified in the patient. F26 relation to the adverse event.
A mild injury, illness or
Problem associated with an undesirable Decreased ability to see to a degree that impairment which can be treated
Opacification A0409 opaqueness or cloudiness. E0839 requires corrective measures F11 with minimal or no intervention.
Problem associated with the materials used No patient involvement or, no observable
to construct the cover or outer wrapping of clinical symptoms or a change in symptoms No apparent harm occurred in
Packaging Problem A0205 the device. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with impairment which can be treated
Pain / Discomfort A24 the device or the way it was used. E0820 Painful sensation in the eye. F11 with minimal or no intervention.
An adverse event (e.g. patient harm) Condition where iris pigment is released
appears to have occurred, but there does into the anterior chamber and deposited in A mild injury, illness or
Pigmentary Dispersion not appear to have been a problem with the trabecular meshwork, due to a impairment which can be treated
/ Glaucoma A24 the device or the way it was used. E0847 procedure or device implantation. F11 with minimal or no intervention.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
Posterior Capsule not appear to have been a problem with Remnant lens epithelial cell proliferation impairment which can be treated
Opacification A24 the device or the way it was used. E0849 and migration to the posterior capsule. F11 with minimal or no intervention.
Problem associated with packaging or No patient involvement or, no observable
shipping damage prior to the use of the clinical symptoms or a change in symptoms No apparent harm occurred in
Received Damaged A0204 device. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm)
appears to have occurred, but there does The clinical signs, symptoms and conditions A mild injury, illness or
not appear to have been a problem with are not adequately described by any other impairment which can be treated
Refractive Error A24 the device or the way it was used. E2402 term. F11 with minimal or no intervention.
An adverse event (e.g. patient harm) A usually small tearing of the retina
appears to have occurred, but there does occurring when the vitreous separates from A mild injury, illness or
Retinal Detachment / not appear to have been a problem with the retina. It may lead to retinal impairment which can be treated
Tear A24 the device or the way it was used. E081905 detachment. F11 with minimal or no intervention.
Ring Falls Out of Problem associated with an inherent device No patient involvement or, no observable No apparent harm occurred in
Injector A0201 characteristic that is not satisfactory as E2403 clinical symptoms or a change in symptoms F26 relation to the adverse event.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 9 of 55
Effects) for Surgical

CATARACT Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
specified or delivered. is identified in the patient.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Rings on Optic A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
No patient involvement or, no observable
Problem associated with shipping damage clinical symptoms or a change in symptoms No apparent harm occurred in
Shipping Damage A0207 or problem prior to the use of the device. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Split Delivery Tip A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Spring Issue A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with a device being
received in such a manner to indicate that
its sterility has been compromised (e.g. No patient involvement or, no observable
sterile packaging breached, visible clinical symptoms or a change in symptoms No apparent harm occurred in
Sterility A020701 contaminate present) E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Syringe Empty A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) An acute postoperative inflammatory
appears to have occurred, but there does reaction in which a noninfectious substance A mild injury, illness or
not appear to have been a problem with enters the anterior segment and induces impairment which can be treated
TASS A24 the device or the way it was used. E0835 toxic damage to the intraocular tissues. F11 with minimal or no intervention.
Problem associated with the undesired No patient involvement or, no observable
characterization of congealing, solidifying, clinical symptoms or a change in symptoms No apparent harm occurred in
Thick A030202 thickening, curdling. E2403 is identified in the patient. F26 relation to the adverse event.
Problem with all or part of an implanted or The clinical signs, symptoms and conditions A mild injury, illness or
invasive device moving from its intended are not adequately described by any other impairment which can be treated
Toric IOL Rotation A010402 location within the body. E2402 term. F11 with minimal or no intervention.
Problem associated with the use of the
device in terms of user experiencing No patient involvement or, no observable
difficulty opening and closing the device, clinical symptoms or a change in symptoms No apparent harm occurred in
Unable to Open A051104 even if the operation is being performed E2403 is identified in the patient. F26 relation to the adverse event.

Viewed/Printed: 6 December 2022 7:36:48 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258685 < > Rev 3 >
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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 10 of 55
Effects) for Surgical

CATARACT Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
according to labeled instructions for use.
Problem associated with users experiencing No patient involvement or, no observable
Unable to Position difficulty or delay to position the device to a clinical symptoms or a change in symptoms No apparent harm occurred in
Properly A150203 specified location. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the use of the
device in terms of user experiencing
difficulty to close or to spread out/extend
length of the device, even if the operation is No patient involvement or, no observable
being performed according to labeled clinical symptoms or a change in symptoms No apparent harm occurred in
Unfolding Issue A051103 instructions for use. E2403 is identified in the patient. F26 relation to the adverse event.
A report has been received but the No patient involvement or, no observable
description provided does not appear to clinical symptoms or a change in symptoms No apparent harm occurred in
Unknown A25 relate to an adverse event. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with impairment which can be treated
Uveitis A24 the device or the way it was used. E0837 Inflammation of the uvea. F11 with minimal or no intervention.
Problem associated with the undesired No patient involvement or, no observable
characterization of congealing, solidifying, clinical symptoms or a change in symptoms No apparent harm occurred in
Viscosity Issue A030202 thickening, curdling. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with impairment which can be treated
Vitreous Fluid Loss A24 the device or the way it was used. E0841 loss or prolapse of vitreous gel. F11 with minimal or no intervention.
Problem associated with an undesired
streak, pattern and/or a noticeable change No patient involvement or, no observable
in color from the rest of the materials used clinical symptoms or a change in symptoms No apparent harm occurred in
Yellow Lens A0407 in the device construction. E2403 is identified in the patient. F26 relation to the adverse event.

II. OPHTHALMIC
OPHTHALMIC Annex A Annex E Annex F
Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
Adverse Event An adverse event (e.g. patient harm) Health effect appears to have occurred but There is not yet enough
A24 appears to have occurred, but there does E2401 there is not yet enough information F24 information available to classify

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Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 11 of 55
Effects) for Surgical

OPHTHALMIC Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
not appear to have been a problem with available to classify the clinical signs, the health impact.
the device or the way it was used. symptoms and conditions.
Bubbles Problem associated with an inherent device No patient involvement or, no observable No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
A0201 specified or delivered. E2403 is identified in the patient. F26
Burrs Problem associated with an undesired Problem associated with an undesired No patient involvement or, no
material change in shape or property material change in shape or property observable clinical symptoms or a
caused by external forces. caused by external forces. change in symptoms is identified
A0406 A0406 E2403 in the patient.
Component Missing A device component(s) found to be missing No patient involvement or, no observable No apparent harm occurred in
when delivered to the user facility. clinical symptoms or a change in symptoms relation to the adverse event.
A020602 E2403 is identified in the patient. F26
Component Not Problems associated with mechanical No patient involvement or, no observable No apparent harm occurred in
Functioning actions or defects, including moving parts clinical symptoms or a change in symptoms relation to the adverse event.
A05 or subassemblies, etc. E2403 is identified in the patient. F26
Damage - Physical Problem associated with undesired damage No patient involvement or, no observable No apparent harm occurred in
or breakage of those materials used in the clinical symptoms or a change in symptoms relation to the adverse event.
A0401 device construction. E2403 is identified in the patient. F26
Deposits / Residue Problem associated with the undesired No patient involvement or, no observable No apparent harm occurred in
introduction of impurities either chemical clinical symptoms or a change in symptoms relation to the adverse event.
or microbiological in nature, or of foreign is identified in the patient.
A1801 matter into or onto the device. E2403 F26
Discolored Problem associated with an undesired No patient involvement or, no observable No apparent harm occurred in
streak, pattern and/or a noticeable change clinical symptoms or a change in symptoms relation to the adverse event.
in color from the rest of the materials used is identified in the patient.
A0407 in the device construction. E2403 F26
Endophthalmitis An adverse event (e.g. patient harm) Inflammation of the intraocular fluids or A mild injury, illness or
appears to have occurred, but there does tissues usually with microbial organisms. impairment which can be treated
not appear to have been a problem with with minimal or no intervention.
A24 the device or the way it was used. E0816 F11
FM / Particulate Substances that consist of separate No patient involvement or, no observable No apparent harm occurred in
particles that are introduced by the device clinical symptoms or a change in symptoms relation to the adverse event.
A030205 during use. E2403 is identified in the patient. F26
Improper Fit Problem associated with a device No patient involvement or, no observable No apparent harm occurred in
A0202 component having flaws of dimensional E2403 clinical symptoms or a change in symptoms F26 relation to the adverse event.

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Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 12 of 55
Effects) for Surgical

OPHTHALMIC Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
deviations greater than acceptable for the is identified in the patient.
intended use.
Inadequate Patient An adverse event (e.g. patient harm) Health effect appears to have occurred but There is not yet enough
Results appears to have occurred, but there does there is not yet enough information information available to classify
not appear to have been a problem with available to classify the clinical signs, the health impact.
A24 the device or the way it was used. E2401 symptoms and conditions. F24
Infection An adverse event (e.g. patient harm) An infection of any part of the eye, A mild injury, illness or
appears to have occurred, but there does including the eyelid. impairment which can be treated
not appear to have been a problem with with minimal or no intervention.
A24 the device or the way it was used. E0818 F11
Inflammation An adverse event (e.g. patient harm) A regionally-limited response to an antigen, A mild injury, illness or
appears to have occurred, but there does which may include inflammation, impairment which can be treated
not appear to have been a problem with induration, erythema, pruritus or pain. with minimal or no intervention.
A24 the device or the way it was used. E040203 F11
Labeling Problem Problem associated with the written, No patient involvement or, no observable No apparent harm occurred in
printed or graphic material accompanying clinical symptoms or a change in symptoms relation to the adverse event.
or affixed to the device or any of its is identified in the patient.
packaging. This includes verbal instructions
relating to identification, technical
description, and usage provided by the
device manufacturers. Problems can include
but are not limited to this material being
unclear, missing, worn out, incorrect or
A2101 inaccurate. E2403 F26
Leak - Air / Fluid Problem associated with the escape of a No patient involvement or, no observable No apparent harm occurred in
liquid, gas or radiation from the vessel or clinical symptoms or a change in symptoms relation to the adverse event.
A0504 container in which it is housed. E2403 is identified in the patient. F26
Miscellaneous Problem associated with an inherent device No patient involvement or, no observable No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
A0201 specified or delivered. E2403 is identified in the patient. F26
Packaging Problem Problem associated with the materials used No patient involvement or, no observable No apparent harm occurred in
to construct the cover or outer wrapping of clinical symptoms or a change in symptoms relation to the adverse event.
A0205 the device. E2403 is identified in the patient. F26
Poor Quality Problem associated with an inherent device No patient involvement or, no observable No apparent harm occurred in
A0201 characteristic that is not satisfactory as E2403 clinical symptoms or a change in symptoms F26 relation to the adverse event.

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Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 13 of 55
Effects) for Surgical

OPHTHALMIC Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
specified or delivered. is identified in the patient.
Received Damaged Problem associated with packaging or No patient involvement or, no observable No apparent harm occurred in
shipping damage prior to the use of the clinical symptoms or a change in symptoms relation to the adverse event.
A0204 device. E2403 is identified in the patient. F26
Residue Problem associated with the undesired No patient involvement or, no observable No apparent harm occurred in
introduction of impurities either chemical clinical symptoms or a change in symptoms relation to the adverse event.
or microbiological in nature, or of foreign is identified in the patient.
A1801 matter into or onto the device. E2403 F26
Sterility Problem associated with a device being No patient involvement or, no observable No apparent harm occurred in
received in such a manner to indicate that clinical symptoms or a change in symptoms relation to the adverse event.
its sterility has been compromised (e.g. is identified in the patient.
sterile packaging breached, visible
A020701 contaminate present) E2403 F26
TASS An adverse event (e.g. patient harm) An acute postoperative inflammatory A mild injury, illness or
appears to have occurred, but there does reaction in which a noninfectious substance impairment which can be treated
not appear to have been a problem with enters the anterior segment and induces with minimal or no intervention.
A24 the device or the way it was used. E0835 toxic damage to the intraocular tissues. F11
Unknown Defect A report has been received but the No patient involvement or, no observable No apparent harm occurred in
description provided does not appear to clinical symptoms or a change in symptoms relation to the adverse event.
A25 relate to an adverse event. E2403 is identified in the patient. F26

III. INSTRUMENTS
INSTRUMENTS Annex A Annex E Annex F
Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with impairment which can be treated
Abrasion A24 the device or the way it was used. E081901 Injury to the epithelium of the cornea. F11 with minimal or no intervention.
An adverse event (e.g. patient harm) Health effect appears to have occurred but
appears to have occurred, but there does there is not yet enough information There is not yet enough
not appear to have been a problem with available to classify the clinical signs, information available to classify
Adverse Event A24 the device or the way it was used. E2401 symptoms and conditions. F24 the health impact.
Problem associated with a circuit, No patient involvement or, no observable No apparent harm occurred in
Alignment A050701 equipment, or system whereby its functions E2403 clinical symptoms or a change in symptoms F26 relation to the adverse event.

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Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 14 of 55
Effects) for Surgical

INSTRUMENTS Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
fail to be properly synchronized or its is identified in the patient.
relative positions properly oriented.
Problem associated with the removal of No patient involvement or, no observable
Aspiration fluid or gas from a body cavity or device due clinical symptoms or a change in symptoms No apparent harm occurred in
No/Low/Weak A141301 to decreased suction. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an undesired No patient involvement or, no observable
material change in shape or property clinical symptoms or a change in symptoms No apparent harm occurred in
Bent A0406 caused by external forces. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with undesired damage No patient involvement or, no observable
or breakage of those materials used in the clinical symptoms or a change in symptoms No apparent harm occurred in
Break / Crack A0401 device construction. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an undesired No patient involvement or, no observable
material change in shape or property clinical symptoms or a change in symptoms No apparent harm occurred in
Burrs A0406 caused by external forces. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with impairment which can be treated
Capsule Damage A24 the device or the way it was used. E0801 A tear in the capsular bag housing the lens. F11 with minimal or no intervention.
Problem related to an obstruction or
blockage within the device component (e.g. No patient involvement or, no observable
tube, opening, pipe) that results in clinical symptoms or a change in symptoms No apparent harm occurred in
Clogged A1409 restriction of flow (including blood clotting). E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the separation of No patient involvement or, no observable
Component the device from its physical construct, clinical symptoms or a change in symptoms No apparent harm occurred in
Detachment A0501 integrity, or chassis. E2403 is identified in the patient. F26 relation to the adverse event.
No patient involvement or, no observable
A device component(s) found to be missing clinical symptoms or a change in symptoms No apparent harm occurred in
Component Missing A020602 when delivered to the user facility. E2403 is identified in the patient. F26 relation to the adverse event.
Problems associated with mechanical No patient involvement or, no observable
Component Not actions or defects, including moving parts clinical symptoms or a change in symptoms No apparent harm occurred in
Functioning A05 or subassemblies, etc. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the chemical or
electrochemical reaction between No patient involvement or, no observable
materials, usually a metal and its clinical symptoms or a change in symptoms No apparent harm occurred in
Corrosion A040502 environment that produces a deterioration E2403 is identified in the patient. F26 relation to the adverse event.

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Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 15 of 55
Effects) for Surgical

INSTRUMENTS Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
of the metal and its properties.
No patient involvement or, no observable
Inability of the device to make an incision, clinical symptoms or a change in symptoms No apparent harm occurred in
Cutting Problem A050702 pierce or open as intended. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with undesired damage No patient involvement or, no observable
or breakage of those materials used in the clinical symptoms or a change in symptoms No apparent harm occurred in
Damage - Physical A0401 device construction. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the undesired
introduction of impurities either chemical No patient involvement or, no observable
or microbiological in nature, or of foreign clinical symptoms or a change in symptoms No apparent harm occurred in
Deposits / Residue A1801 matter into or onto the device. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an undesired
streak, pattern and/or a noticeable change No patient involvement or, no observable
in color from the rest of the materials used clinical symptoms or a change in symptoms No apparent harm occurred in
Discolored A0407 in the device construction. E2403 is identified in the patient. F26 relation to the adverse event.
No patient involvement or, no observable
Problem associated with a device not being clinical symptoms or a change in symptoms No apparent harm occurred in
Dull A020101 as sharp as intended or expected. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with Inflammation of the intraocular fluids or impairment which can be treated
Endophthalmitis A24 the device or the way it was used. E0816 tissues usually with microbial organisms. F11 with minimal or no intervention.
Substances that consist of separate No patient involvement or, no observable
particles that are introduced by the device clinical symptoms or a change in symptoms No apparent harm occurred in
FM / Particulate A030205 during use. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with a device
component having flaws of dimensional No patient involvement or, no observable
deviations greater than acceptable for the clinical symptoms or a change in symptoms No apparent harm occurred in
Improper Fit A0202 intended use. E2403 is identified in the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) Health effect appears to have occurred but
appears to have occurred, but there does there is not yet enough information There is not yet enough
Inadequate Patient not appear to have been a problem with available to classify the clinical signs, information available to classify
Results A24 the device or the way it was used. E2401 symptoms and conditions. F24 the health impact.
Problem associated with a device No patient involvement or, no observable No apparent harm occurred in
Incorrect Size/Shape A0202 component having flaws of dimensional E2403 clinical symptoms or a change in symptoms F26 relation to the adverse event.

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Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 16 of 55
Effects) for Surgical

INSTRUMENTS Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
deviations greater than acceptable for the is identified in the patient.
intended use.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A mild injury, illness or
not appear to have been a problem with An infection of any part of the eye, impairment which can be treated
Infection A24 the device or the way it was used. E0818 including the eyelid. F11 with minimal or no intervention.
An adverse event (e.g. patient harm)
appears to have occurred, but there does A regionally-limited response to an antigen, A mild injury, illness or
not appear to have been a problem with which may include inflammation, impairment which can be treated
Inflammation A24 the device or the way it was used. E040203 induration, erythema, pruritus or pain. F11 with minimal or no intervention.
Problem associated with the device failing
to deliver or draw liquids or gases as
intended (e.g. delivering drugs at incorrect
rate, Problems with drawing fluid from a No patient involvement or, no observable
Irrigation - Slow / system). This includes vacuum collection clinical symptoms or a change in symptoms No apparent harm occurred in
Weak A14 devices. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the written,
printed or graphic material accompanying
or affixed to the device or any of its
packaging. This includes verbal instructions
relating to identification, technical
description, and usage provided by the
device manufacturers. Problems can include
but are not limited to this material being No patient involvement or, no observable
unclear, missing, worn out, incorrect or clinical symptoms or a change in symptoms No apparent harm occurred in
Labeling Problem A2101 inaccurate. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the escape of a No patient involvement or, no observable
liquid, gas or radiation from the vessel or clinical symptoms or a change in symptoms No apparent harm occurred in
Leak - Air / Fluid A0504 container in which it is housed. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with the materials used No patient involvement or, no observable
to construct the cover or outer wrapping of clinical symptoms or a change in symptoms No apparent harm occurred in
Packaging Problem A0205 the device. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with packaging or No patient involvement or, no observable
shipping damage prior to the use of the clinical symptoms or a change in symptoms No apparent harm occurred in
Received Damaged A0204 device. E2403 is identified in the patient. F26 relation to the adverse event.

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Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 17 of 55
Effects) for Surgical

INSTRUMENTS Annex A Annex E Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition Annex F Health Impact Definition
Problem associated with the undesired
introduction of impurities either chemical No patient involvement or, no observable
or microbiological in nature, or of foreign clinical symptoms or a change in symptoms No apparent harm occurred in
Residue A1801 matter into or onto the device. E2403 is identified in the patient. F26 relation to the adverse event.
No patient involvement or, no observable
Problem associated with shipping damage clinical symptoms or a change in symptoms No apparent harm occurred in
Shipping Damage A0207 or problem prior to the use of the device. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Sleeve Defective A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with a device being
received in such a manner to indicate that
its sterility has been compromised (e.g. No patient involvement or, no observable
sterile packaging breached, visible clinical symptoms or a change in symptoms No apparent harm occurred in
Sterility A020701 contaminate present) E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Sticking / Locked Up A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an undesired No patient involvement or, no observable
material change in shape or property clinical symptoms or a change in symptoms No apparent harm occurred in
Surface Defect A0406 caused by external forces. E2403 is identified in the patient. F26 relation to the adverse event.
Problem associated with an inherent device No patient involvement or, no observable
characteristic that is not satisfactory as clinical symptoms or a change in symptoms No apparent harm occurred in
Tubing A0201 specified or delivered. E2403 is identified in the patient. F26 relation to the adverse event.
A report has been received but the No patient involvement or, no observable
description provided does not appear to clinical symptoms or a change in symptoms No apparent harm occurred in
Unknown Defect A25 relate to an adverse event. E2403 is identified in the patient. F26 relation to the adverse event.

IV. IAVP and SYNERGETICS

IAVP/SYNERGETICS Annex A Annex E Annex Annex F
Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
A report has been received but the description Surgical procedure unable to be
provided does not appear to relate to an completed when originally
Aborted Procedure A25 adverse event. E21 Procedural Complications F1909 scheduled and put off until some

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Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 18 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
time in the future.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to A mild injury, illness or impairment
have been a problem with the device or the which can be treated with minimal
Abrasion A24 way it was used. E081901 Injury to the epithelium of the cornea. F11 or no intervention.
The unintentional exposure to
radiation of a person, or a part of a
Device-emitted radiation when it was not persons body. This might include
supposed to. This applies to devices which are exposure of a healthcare professional,
intended to emit radiation, and the radiation or the exposure of the wrong part of
being emitted from the correct part of the the body of a patient who was
device, but at an incorrect time. Use "radiation intended to receive therapeutic or
leak" if the device emits radiation which should diagnostic radiation. This includes There is not yet enough
Accidental Radiation never have been emitted, or from a location both ionizing and non ionizing information available to classify
Occurrence A090504 from which it should never be emitted. E2119 radiation. F24 the health impact.
Health effect appears to have
An adverse event (e.g. patient harm) appears occurred but there is not yet enough
to have occurred, but there does not appear to information available to classify the There is not yet enough
have been a problem with the device or the clinical signs, symptoms and information available to classify
Adverse Event A24 way it was used. E2401 conditions. F24 the health impact.
No patient involvement or, no
Problem associated with the removal of fluid observable clinical symptoms or a
Aspiration No / Low / or gas from a body cavity or device due to change in symptoms is identified in No apparent harm occurred in
Weak A141301 decreased suction. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with the removal of fluid observable clinical symptoms or a
Aspiration Overshoot / or gas from a body cavity or device due to change in symptoms is identified in No apparent harm occurred in
Surge A141302 increased suction. E2403 the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to A mild injury, illness or impairment
have been a problem with the device or the Decreased ability to see to a degree which can be treated with minimal
Astigmatism A24 way it was used. E0839 that requires corrective measures F11 or no intervention.
Problem with any deviation from the No patient involvement or, no
documented specifications of the device that observable clinical symptoms or a No apparent harm occurred in
Audio Problems A0901 relate to audible feedback. e.g. voice prompts E2403 change in symptoms is identified in F26 relation to the adverse event.

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Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 19 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
or beeps, but not safety related alarms which the patient.
are covered under "Protective Measures
Problem".
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to A mild injury, illness or impairment
have been a problem with the device or the Decreased ability to see to a degree which can be treated with minimal
BCVA Loss A24 way it was used. E0839 that requires corrective measures F11 or no intervention.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with the device not change in symptoms is identified in No apparent harm occurred in
Bipolar Problem A0505 discharging as intended. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Bubbles A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to A mild injury, illness or impairment
have been a problem with the device or the Burn injury, including chemical burn, which can be treated with minimal
Burn A24 way it was used. E081902 to any part of the eye. F11 or no intervention.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with an unexpected or change in symptoms is identified in No apparent harm occurred in
Burnt Smell A0301 inappropriate smell released by the device. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an undesired material observable clinical symptoms or a
change in shape or property caused by external change in symptoms is identified in No apparent harm occurred in
Burrs A0406 forces. E2403 the patient. F26 relation to the adverse event.
Problem associated with any deviations from No patient involvement or, no
the documented specifications of the device observable clinical symptoms or a
that relate to the limited durability of all change in symptoms is identified in No apparent harm occurred in
Cable / Cord Damage A04 material used to construct device. E2403 the patient. F26 relation to the adverse event.
Problem associated with the failure of the No patient involvement or, no
device to perform a self-calibration procedure observable clinical symptoms or a
or process designed to assure the accuracy and change in symptoms is identified in No apparent harm occurred in
Calibration Error A0801 proper performance of the device. E2403 the patient. F26 relation to the adverse event.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 20 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to A mild injury, illness or impairment
have been a problem with the device or the A tear in the capsular bag housing the which can be treated with minimal
Capsule Damage A24 way it was used. E0801 lens. F11 or no intervention.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Cassette / Cartridge A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
Problem related to an obstruction or blockage No patient involvement or, no
within the device component (e.g. tube, observable clinical symptoms or a
opening, pipe) that results in restriction of flow change in symptoms is identified in No apparent harm occurred in
Clogged A1409 (including blood clotting). E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Color filter error A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
Problem associated with the device sending or
receiving signals or data. This includes No patient involvement or, no
transmission among internal components of observable clinical symptoms or a
the device to which the device is intended to change in symptoms is identified in No apparent harm occurred in
Communication A13 communicate. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with the separation of the observable clinical symptoms or a
Component device from its physical construct, integrity, or change in symptoms is identified in No apparent harm occurred in
Detachment A0501 chassis. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
A device component(s) found to be missing change in symptoms is identified in No apparent harm occurred in
Component Missing A020602 when delivered to the user facility. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problems associated with mechanical actions observable clinical symptoms or a
Component Not or defects, including moving parts or change in symptoms is identified in No apparent harm occurred in
Functioning A05 subassemblies, etc. E2403 the patient. F26 relation to the adverse event.
Problem associated with software, firmware, No patient involvement or, no No apparent harm occurred in
Computer Problem A1104 and/or hardware elements that control the E2403 observable clinical symptoms or a F26 relation to the adverse event.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 21 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
execution of computer programs and provides change in symptoms is identified in
such services as computer resource allocation, the patient.
job control, input/output control, and file
management in a computer system.
Problem associated with linking of the device No patient involvement or, no
and/or the functional units set up to provide observable clinical symptoms or a
means for a transfer of liquid, gas, electricity or change in symptoms is identified in No apparent harm occurred in
Connector A12 data. E2403 the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to A mild injury, illness or impairment
have been a problem with the device or the which can be treated with minimal
Corneal Edema A24 way it was used. E0807 Hazy, swollen cornea. F11 or no intervention.
Problem associated with the chemical or
electrochemical reaction between materials, No patient involvement or, no
usually a metal and its environment that observable clinical symptoms or a
produces a deterioration of the metal and its change in symptoms is identified in No apparent harm occurred in
Corrosion / Rust A040502 properties. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Inability of the device to make an incision, change in symptoms is identified in No apparent harm occurred in
Cutting Problem A050702 pierce or open as intended. E2403 the patient. F26 relation to the adverse event.
No Clinical Signs, Symptoms or
Cybersecurity Issue A1105 Computer System Security Problem E2403 Conditions F27 No Patient Involvement
An adverse event (e.g. patient harm) appears Accumulation of intraretinal fluid and
to have occurred, but there does not appear to protein in the macula, which may A mild injury, illness or impairment
Cystoid Macular have been a problem with the device or the result in swelling and decreased which can be treated with minimal
Edema A24 way it was used. E0830 central vision. F11 or no intervention.
No patient involvement or, no
Problem associated with undesired damage or observable clinical symptoms or a
breakage of those materials used in the device change in symptoms is identified in No apparent harm occurred in
Damage - Physical A0401 construction. E2403 the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to The clinical signs, symptoms and
have been a problem with the device or the conditions are not adequately
Death A24 way it was used. E2402 described by any other term. F02 The cessation of life.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 22 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
Problem associated with the undesired No patient involvement or, no
introduction of impurities either chemical or observable clinical symptoms or a
microbiological in nature, or of foreign matter change in symptoms is identified in No apparent harm occurred in
Deposits / Residue A1801 into or onto the device. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Device / Component observable clinical symptoms or a
Will Not Move / Turn The motion of the device is prevented or change in symptoms is identified in No apparent harm occurred in
Correctly A0506 restricted. E2403 the patient. F26 relation to the adverse event.
Problem associated with an undesired streak, No patient involvement or, no
pattern and/or a noticeable change in color observable clinical symptoms or a
from the rest of the materials used in the change in symptoms is identified in No apparent harm occurred in
Discolored A0407 device construction. E2403 the patient. F26 relation to the adverse event.
Problem with any deviation from the
documented specifications of the device that No patient involvement or, no
relate to visual feedback. e.g. the display of observable clinical symptoms or a
Display / Screen / information, images on a screen, or output change in symptoms is identified in No apparent harm occurred in
Video A0902 from the device. E2403 the patient. F26 relation to the adverse event.
Problem associated with the use of the device
in terms of user experiencing difficulty opening No patient involvement or, no
and closing the device, even if the operation is observable clinical symptoms or a
being performed according to labeled change in symptoms is identified in No apparent harm occurred in
Drawer Problem A051104 instructions for use. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with a device not being as change in symptoms is identified in No apparent harm occurred in
Dull A020101 sharp as intended or expected. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an electric current observable clinical symptoms or a
travelling along an accidental path (unintended change in symptoms is identified in No apparent harm occurred in
Electrical Failure A072102 path) in a circuit. E2403 the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to Inflammation of the intraocular fluids A mild injury, illness or impairment
have been a problem with the device or the or tissues usually with microbial which can be treated with minimal
Endophthalmitis A24 way it was used. E0816 organisms. F11 or no intervention.
Error Message A25 A report has been received but the description E2403 No patient involvement or, no F26 No apparent harm occurred in

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 23 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
provided does not appear to relate to an observable clinical symptoms or a relation to the adverse event.
adverse event. change in symptoms is identified in
the patient.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Expired Product A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
A report has been received but the description observable clinical symptoms or a
Fluid Level Detection provided does not appear to relate to an change in symptoms is identified in No apparent harm occurred in
Error A25 adverse event. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Substances that consist of separate particles change in symptoms is identified in No apparent harm occurred in
FM / Particulate A030205 that are introduced by the device during use. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Foot Pedal Problem A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Hard Drive Failure A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Illumination Problem A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with a device component observable clinical symptoms or a
having flaws of dimensional deviations greater change in symptoms is identified in No apparent harm occurred in
Improper Fit A0202 than acceptable for the intended use. E2403 the patient. F26 relation to the adverse event.
Problem associated with the device that does No patient involvement or, no
not meet the specifications or requirements observable clinical symptoms or a
for which it was manufactured (e.g. materials, change in symptoms is identified in No apparent harm occurred in
Incorrect Component A020102 parts, manufacturing process). E2403 the patient. F26 relation to the adverse event.

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 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 24 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
No patient involvement or, no
Problem associated with a device component observable clinical symptoms or a
having flaws of dimensional deviations greater change in symptoms is identified in No apparent harm occurred in
Incorrect Size/Shape A0202 than acceptable for the intended use. E2403 the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to A mild injury, illness or impairment
have been a problem with the device or the An infection of any part of the eye, which can be treated with minimal
Infection A24 way it was used. E0818 including the eyelid. F11 or no intervention.
An adverse event (e.g. patient harm) appears A regionally-limited response to an
to have occurred, but there does not appear to antigen, which may include A mild injury, illness or impairment
have been a problem with the device or the inflammation, induration, erythema, which can be treated with minimal
Inflammation A24 way it was used. E040203 pruritus or pain. F11 or no intervention.
Problem associated with problems introducing No patient involvement or, no
or inserting the device, even if the user is observable clinical symptoms or a
operating the device in accordance with the change in symptoms is identified in No apparent harm occurred in
Insertion Difficulties A150206 instructions for use or labeling. E2403 the patient. F26 relation to the adverse event.
A report has been received but the description
Intraocular Pressure provided does not appear to relate to an Decrease of pressure of the No apparent harm occurred in
(IOP) Unstable A25 adverse event. E0826 intraocular fluid in the eye. F26 relation to the adverse event.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to A mild injury, illness or impairment
have been a problem with the device or the which can be treated with minimal
Iris Prolapse / Damage A24 way it was used. E0819 Damage to the eye. F11 or no intervention.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to A mild injury, illness or impairment
have been a problem with the device or the which can be treated with minimal
Iritis A24 way it was used. E0828 Inflammation of the iris. F11 or no intervention.
Problem associated with the device failing to
deliver or draw liquids or gases as intended No patient involvement or, no
(e.g. delivering drugs at incorrect rate, observable clinical symptoms or a
Problems with drawing fluid from a system). change in symptoms is identified in No apparent harm occurred in
Irrigation - Continuous A14 This includes vacuum collection devices. E2403 the patient. F26 relation to the adverse event.
Problem associated with the device failing to No patient involvement or, no
Irrigation - High / Too deliver or draw liquids or gases as intended observable clinical symptoms or a No apparent harm occurred in
Much Force A14 (e.g. delivering drugs at incorrect rate, E2403 change in symptoms is identified in F26 relation to the adverse event.

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 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 25 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
Problems with drawing fluid from a system). the patient.
This includes vacuum collection devices.
Problem associated with the device failing to
deliver or draw liquids or gases as intended No patient involvement or, no
(e.g. delivering drugs at incorrect rate, observable clinical symptoms or a
Irrigation - Slow / Problems with drawing fluid from a system). change in symptoms is identified in No apparent harm occurred in
Weak A14 This includes vacuum collection devices. E2403 the patient. F26 relation to the adverse event.
Problem associated with the written, printed
or graphic material accompanying or affixed to
the device or any of its packaging. This includes
verbal instructions relating to identification,
technical description, and usage provided by
the device manufacturers. Problems can No patient involvement or, no
include but are not limited to this material observable clinical symptoms or a
being unclear, missing, worn out, incorrect or change in symptoms is identified in No apparent harm occurred in
Labeling Problem A2101 inaccurate. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Laser - Laser Won't Problem associated with the device not change in symptoms is identified in No apparent harm occurred in
Fire A0505 discharging as intended. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Laser - Low Power Problem associated with the device not change in symptoms is identified in No apparent harm occurred in
from LIO A0505 discharging as intended. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Laser - Message LAS06 Problem associated with the device not change in symptoms is identified in No apparent harm occurred in
Laser Malfunction A0505 discharging as intended. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Laser - No LIO Lamp Problem associated with the device not change in symptoms is identified in No apparent harm occurred in
Illumination A0505 discharging as intended. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Laser - No Red Aiming Problem associated with the device not observable clinical symptoms or a No apparent harm occurred in
Beam A0505 discharging as intended. E2403 change in symptoms is identified in F26 relation to the adverse event.

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 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 26 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
the patient.
No patient involvement or, no
observable clinical symptoms or a
Laser - No Treat Problem associated with the device not change in symptoms is identified in No apparent harm occurred in
Result/No Laser Burn A0505 discharging as intended. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Laser - Other Laser Problem associated with the device not change in symptoms is identified in No apparent harm occurred in
Message A0505 discharging as intended. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
Laser - Prob w/Adjust characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Control(s) LIO A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
Laser - Vis Image in LIO characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Unable to Fuse A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with the escape of a liquid, observable clinical symptoms or a
gas or radiation from the vessel or container in change in symptoms is identified in No apparent harm occurred in
Leak - Air / Fluid A0504 which it is housed. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Miscellaneous A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with the device not change in symptoms is identified in No apparent harm occurred in
No Laser Output A0505 discharging as intended. E2403 the patient. F26 relation to the adverse event.
Problem associated with any unintended
sound which emanates from the device (for No patient involvement or, no
example, squeaking from two parts rubbing observable clinical symptoms or a
together or buzzing sounds from electrical change in symptoms is identified in No apparent harm occurred in
Noise A0508 components). E2403 the patient. F26 relation to the adverse event.
Overheating / A10 Problem associated with the device producing E2403 No patient involvement or, no F26 No apparent harm occurred in

Viewed/Printed: 6 December 2022 7:36:48 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258685 < > Rev 3 >
 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 27 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
Temperature Problem unintended temperatures. observable clinical symptoms or a relation to the adverse event.
change in symptoms is identified in
the patient.
No patient involvement or, no
Problem associated with the materials used to observable clinical symptoms or a
construct the cover or outer wrapping of the change in symptoms is identified in No apparent harm occurred in
Packaging Problem A0205 device. E2403 the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to A mild injury, illness or impairment
have been a problem with the device or the which can be treated with minimal
Pain / Discomfort A24 way it was used. E0820 Painful sensation in the eye. F11 or no intervention.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
PC Accessory Problem A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to Increased pressure in the eyeball due A mild injury, illness or impairment
Pigmentary Dispersion have been a problem with the device or the to obstruction of the outflow of which can be treated with minimal
/ Glaucoma A24 way it was used. E0822 aqueous humor. F11 or no intervention.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to Remnant lens epithelial cell A mild injury, illness or impairment
Posterior Capsule have been a problem with the device or the proliferation and migration to the which can be treated with minimal
Opacification A24 way it was used. E0849 posterior capsule. F11 or no intervention.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with the energy to operate change in symptoms is identified in No apparent harm occurred in
Power Inadequate A0708 the device. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with the energy to operate change in symptoms is identified in No apparent harm occurred in
Power Too High A0708 the device. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with the device failing to observable clinical symptoms or a
begin the priming process (i.e. the process of change in symptoms is identified in No apparent harm occurred in
Prime, Failure To . . . A141401 preparation of device for the delivery of fluids). E2403 the patient. F26 relation to the adverse event.

Viewed/Printed: 6 December 2022 7:36:48 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258685 < > Rev 3 >
 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 28 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
No patient involvement or, no
Problem associated with pump performance observable clinical symptoms or a
deviating from specifications in a way to change in symptoms is identified in No apparent harm occurred in
Pump Failure A1412 compromise flow or infusion. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with a nonconforming end observable clinical symptoms or a
result, data, or test results provided by the change in symptoms is identified in No apparent harm occurred in
Readings Inaccurate A0908 device to its performance specifications. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with packaging or shipping change in symptoms is identified in No apparent harm occurred in
Received Damaged A0204 damage prior to the use of the device. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Recognition Failure A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with partial backflow, change in symptoms is identified in No apparent harm occurred in
Reflux A140507 compromising the device's flow output. E2403 the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) appears A usually small tearing of the retina
to have occurred, but there does not appear to occurring when the vitreous separates A mild injury, illness or impairment
Retinal Detachment / have been a problem with the device or the from the retina. It may lead to retinal which can be treated with minimal
Tear A24 way it was used. E081905 detachment. F11 or no intervention.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with shipping damage or change in symptoms is identified in No apparent harm occurred in
Shipping Damage A0207 problem prior to the use of the device. E2403 the patient. F26 relation to the adverse event.
The device delivers unintended electrical A shock caused by a brief, A mild injury, illness or impairment
shock. Use this term for devices that are not unintentional exposure to an electric which can be treated with minimal
Shock A0714 intended to deliver shocks/stimulation. E2104 current from a device. F11 or no intervention.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Sleeve Defective A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.

Viewed/Printed: 6 December 2022 7:36:48 AM **Confidential GDMS-D2 Copy-Use per procedure** REF-000258685 < > Rev 3 >
 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 29 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
No patient involvement or, no
Problem associated with a cloud of vapor or observable clinical symptoms or a
gas generated from the device, generally change in symptoms is identified in No apparent harm occurred in
Smoke A1009 associated after a fire or a burn. E2403 the patient. F26 relation to the adverse event.
Computer Software Problem. Problem
associated with written programs, codes, No patient involvement or, no
and/or software system that affects device observable clinical symptoms or a
performance or communication with another change in symptoms is identified in No apparent harm occurred in
Software Problem A11 device. E2403 the patient. F26 relation to the adverse event.
Problem associated with a device being
received in such a manner to indicate that its No patient involvement or, no
sterility has been compromised (e.g. sterile observable clinical symptoms or a
packaging breached, visible contaminate change in symptoms is identified in No apparent harm occurred in
Sterility A020701 present) E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with the device change in symptoms is identified in No apparent harm occurred in
System Shutdown A0719 unexpectedly powering down. E2403 the patient. F26 relation to the adverse event.
An acute postoperative inflammatory
An adverse event (e.g. patient harm) appears reaction in which a noninfectious
to have occurred, but there does not appear to substance enters the anterior A mild injury, illness or impairment
have been a problem with the device or the segment and induces toxic damage to which can be treated with minimal
TASS A24 way it was used. E0835 the intraocular tissues. F11 or no intervention.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
Treatment characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Interruption A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Tubing Defect A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
Problem associated with the failure of the No patient involvement or, no
device to perform a self-calibration procedure observable clinical symptoms or a
or process designed to assure the accuracy and change in symptoms is identified in No apparent harm occurred in
Tuning failure A0801 proper performance of the device. E2403 the patient. F26 relation to the adverse event.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 30 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Ultrasound Problem A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with early and unexpected change in symptoms is identified in No apparent harm occurred in
Unintended Activation A150103 activation of the device. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
A report has been received but the description observable clinical symptoms or a
provided does not appear to relate to an change in symptoms is identified in No apparent harm occurred in
Unknown A25 adverse event. E2403 the patient. F26 relation to the adverse event.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to A mild injury, illness or impairment
have been a problem with the device or the which can be treated with minimal
Uveitis A24 way it was used. E0837 Inflammation of the uvea. F11 or no intervention.
Problem associated with suction equipment,
which may be a manual, electrical, vacuum or No patient involvement or, no
pressure source operated to evacuate and observable clinical symptoms or a
remove undesired substances (air, gas, fluid, or change in symptoms is identified in No apparent harm occurred in
Vacuum / Suction A1413 particulates) via tubing and collection bag. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Valve Defect A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with the undesirable change in symptoms is identified in No apparent harm occurred in
Vibration A051208 mechanical oscillation. E2403 the patient. F26 relation to the adverse event.
No patient involvement or, no
Problem associated with an inherent device observable clinical symptoms or a
characteristic that is not satisfactory as change in symptoms is identified in No apparent harm occurred in
Viscous Fluid Problem A0201 specified or delivered. E2403 the patient. F26 relation to the adverse event.
Problem associated with the device failing to No patient involvement or, no No apparent harm occurred in
Vitrectomy Function A150101 be activated including partial activation. E2403 observable clinical symptoms or a F26 relation to the adverse event.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 31 of 55
Effects) for Surgical

IAVP/SYNERGETICS Annex A Annex E Annex Annex F

Complaint Reason Annex A Device Problem Definition Annex E Clinical Symptoms Definition F Health Impact Definition
change in symptoms is identified in
the patient.
An adverse event (e.g. patient harm) appears
to have occurred, but there does not appear to A mild injury, illness or impairment
have been a problem with the device or the which can be treated with minimal
Vitreous Fluid Loss A24 way it was used. E0841 loss or prolapse of vitreous gel. F11 or no intervention.
No patient involvement or, no
observable clinical symptoms or a
Problem associated with the device failing to change in symptoms is identified in No apparent harm occurred in
Will Not Boot A150101 be activated including partial activation. E2403 the patient. F26 relation to the adverse event.

V. REFRACTIVE
REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F
Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
AMPLIFIER DOES NOT A150101 Problem associated with the device failing to E2403 No patient involvement or, no observable F26 No apparent harm occurred in
START be activated including partial activation. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
APPLICATION ERROR A1102 Problem associated with the requirement E2403 No patient involvement or, no observable F26 No apparent harm occurred in
for software to fulfill its function within an clinical symptoms or a change in symptoms relation to the adverse event.
intended use or application. is identified in the patient.
ARCHIVING A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
BACKLASH ON CONE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
BACKUP PROCESS A110601 Problem associated with the inability to E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED backup or to retrieve a backed up version clinical symptoms or a change in symptoms relation to the adverse event.
(corrupted file) of device data or system is identified in the patient.
files.
BAD ALIGNMENT A050701 Problem associated with a circuit, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
equipment, or system whereby its functions clinical symptoms or a change in symptoms relation to the adverse event.
fail to be properly synchronized or its is identified in the patient.
relative positions properly oriented.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 32 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
BAD CENTROIDS A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
BEAM ADJUSTMENT A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
BED DEFECTICE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
BED HAS NO POWER A0708 Problem associated with the energy to E2403 No patient involvement or, no observable F26 No apparent harm occurred in
operate the device. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
BED MOVEMENT A0506 The motion of the device is prevented or E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILURE restricted. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
BULB LAMP BROKEN A0401 Problem associated with undesired damage E2403 No patient involvement or, no observable F26 No apparent harm occurred in
or breakage of those materials used in the clinical symptoms or a change in symptoms relation to the adverse event.
device construction. is identified in the patient.
CALIBRATION ERROR A0801 Problem associated with the failure of the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
device to perform a self-calibration clinical symptoms or a change in symptoms relation to the adverse event.
procedure or process designed to assure the is identified in the patient.
accuracy and proper performance of the
device.
CALIBRATION FAILED A0801 Problem associated with the failure of the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
device to perform a self-calibration clinical symptoms or a change in symptoms relation to the adverse event.
procedure or process designed to assure the is identified in the patient.
accuracy and proper performance of the
device.
CAMERA FAILURE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
CANNOT A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
ACQUIRE/MEASURE characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
CANNOT OPEN A1103 Problem associated with execution problems E2403 No patient involvement or, no observable F26 No apparent harm occurred in

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 33 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
PROGRAM relating to program or algorithm. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
CEF - SC3 DOCKING A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
PROBLEM characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
CHILLER DEFECTIVE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
CHILLER DOES NOT A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
WORK characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
CHILLER FILTER IS A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
BLOCKED characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
CHILLER FLOW ERROR A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
CHILLER A10 Problem associated with the device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
TEMPERATURE producing unintended temperatures. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
CHILLER WATER DIRTY A1801 Problem associated with the undesired E2403 No patient involvement or, no observable F26 No apparent harm occurred in
introduction of impurities either chemical or clinical symptoms or a change in symptoms relation to the adverse event.
microbiological in nature, or of foreign is identified in the patient.
matter into or onto the device.
CLIP OPEN AND CLOSE A051104 Problem associated with the use of the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
TOO HARD device in terms of user experiencing clinical symptoms or a change in symptoms relation to the adverse event.
difficulty opening and closing the device, is identified in the patient.
even if the operation is being performed
according to labeled instructions for use.
COMMUNICATION TO A13 Problem associated with the device sending E2403 No patient involvement or, no observable F26 No apparent harm occurred in
HEAD LOST or receiving signals or data. This includes clinical symptoms or a change in symptoms relation to the adverse event.
transmission among internal components of is identified in the patient.
the device to which the device is intended to
communicate.
CONE IS DAMAGED A0401 Problem associated with undesired damage E2403 No patient involvement or, no observable F26 No apparent harm occurred in

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 34 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
or breakage of those materials used in the clinical symptoms or a change in symptoms relation to the adverse event.
device construction. is identified in the patient.
CONTAMINATION A1801 Problem associated with the undesired E2403 No patient involvement or, no observable F26 No apparent harm occurred in
introduction of impurities either chemical or clinical symptoms or a change in symptoms relation to the adverse event.
microbiological in nature, or of foreign is identified in the patient.
matter into or onto the device.
CONTROL ACCESSORY A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
CUTTING LENS IS A1801 Problem associated with the undesired E2403 No patient involvement or, no observable F26 No apparent harm occurred in
DIRTY introduction of impurities either chemical or clinical symptoms or a change in symptoms relation to the adverse event.
microbiological in nature, or of foreign is identified in the patient.
matter into or onto the device.
CUTTING LENS IS NOT A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FIX characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
DAMAGED A0205 Problem associated with the materials used E2403 No patient involvement or, no observable F26 No apparent harm occurred in
PACKAGING to construct the cover or outer wrapping of clinical symptoms or a change in symptoms relation to the adverse event.
the device. is identified in the patient.
DAMAGED PART A0401 Problem associated with undesired damage E2403 No patient involvement or, no observable F26 No apparent harm occurred in
or breakage of those materials used in the clinical symptoms or a change in symptoms relation to the adverse event.
device construction. is identified in the patient.
DATA TRANSFER A1103 Problem associated with execution problems E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED relating to program or algorithm. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
DATA TRANSFER A1103 Problem associated with execution problems E2403 No patient involvement or, no observable F26 No apparent harm occurred in
INCOMPLETE relating to program or algorithm. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
DATABASE ACCESS A1104 Problem associated with software, firmware, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
and/or hardware elements that control the clinical symptoms or a change in symptoms relation to the adverse event.
execution of computer programs and is identified in the patient.
provides such services as computer resource
allocation, job control, input/output control,
and file management in a computer system.
DENT A040602 Problem associated with a undesired change E2403 No patient involvement or, no observable F26 No apparent harm occurred in

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 35 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
in shape, characterized by the presence of a clinical symptoms or a change in symptoms relation to the adverse event.
slight hollow (dent) in the device surface. is identified in the patient.
DLK A24 An adverse event (e.g. patient harm) E0829 Inflammation of the cornea. F24 There is not yet enough
appears to have occurred, but there does information available to classify
not appear to have been a problem with the the health impact.
device or the way it was used.
DRIVE ASSY- A1801 Problem associated with the undesired E2403 No patient involvement or, no observable F26 No apparent harm occurred in
CONTAMINATION introduction of impurities either chemical or clinical symptoms or a change in symptoms relation to the adverse event.
microbiological in nature, or of foreign is identified in the patient.
matter into or onto the device.
DRIVE ASSY-JAMMED A0506 The motion of the device is prevented or E2403 No patient involvement or, no observable F26 No apparent harm occurred in
restricted. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
DRIVE ASSY-WORN A0506 The motion of the device is prevented or E2403 No patient involvement or, no observable F26 No apparent harm occurred in
OUT restricted. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
DULL A020101 Problem associated with a device not being E2403 No patient involvement or, no observable F26 No apparent harm occurred in
as sharp as intended or expected. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
EHD FAILURE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
ELECTRIC UNIT A07 Problem associated with a failure of the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILURE electrical circuitry of the device. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
EMON FAILED A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
EMON OUT OF RANGE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
EMON SHUTTER A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
ERROR characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
ENERGY CALIBRATION A07 Problem associated with a failure of the E2403 No patient involvement or, no observable F26 No apparent harm occurred in

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 36 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
FAILURE electrical circuitry of the device. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
ENERGY CHECK ERROR A07 Problem associated with a failure of the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
electrical circuitry of the device. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
ENERGY CONTROL A07 Problem associated with a failure of the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED electrical circuitry of the device. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
ENERGY PROBLEM A07 Problem associated with a failure of the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
electrical circuitry of the device. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
ERROR MESSAGE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
EVACUATION TIME TO A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
LOW characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
EXCESSIVE VACUUM A1412 Problem associated with pump performance E2403 No patient involvement or, no observable F26 No apparent harm occurred in
PUMP deviating from specifications in a way to clinical symptoms or a change in symptoms relation to the adverse event.
compromise flow or infusion. is identified in the patient.
EXCIMER BEAM OUT A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
OF SPEC characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
EYETRACKER FAILED A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
EYETRACKER IRIS A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
RECOGNITION characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
FAILURE specified or delivered. is identified in the patient.
FEMTOCLICK IS NOT A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
WORKING characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
FIXATION LASER IS A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
MISALIGNED characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 37 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
FLUID LEAKAGE A0504 Problem associated with the escape of a E2403 No patient involvement or, no observable F26 No apparent harm occurred in
liquid, gas or radiation from the vessel or clinical symptoms or a change in symptoms relation to the adverse event.
container in which it is housed. is identified in the patient.
FOCUSPOINT IS A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
WRONG characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
GAS ARF CHANGE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
GAS CHANGE FAILED A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
GAS LEAKAGE A050402 Problem associated with the unintended E2403 No patient involvement or, no observable F26 No apparent harm occurred in
escape of a gas from the container in which clinical symptoms or a change in symptoms relation to the adverse event.
it is housed. is identified in the patient.
GAS N2 FLUSH FAILED A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
GUI PC BOOT ERROR A1104 Problem associated with software, firmware, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
and/or hardware elements that control the clinical symptoms or a change in symptoms relation to the adverse event.
execution of computer programs and is identified in the patient.
provides such services as computer resource
allocation, job control, input/output control,
and file management in a computer system.
GUI PC CRASHED A1104 Problem associated with software, firmware, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
and/or hardware elements that control the clinical symptoms or a change in symptoms relation to the adverse event.
execution of computer programs and is identified in the patient.
provides such services as computer resource
allocation, job control, input/output control,
and file management in a computer system.
GUI PC ERROR A1104 Problem associated with software, firmware, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
and/or hardware elements that control the clinical symptoms or a change in symptoms relation to the adverse event.
execution of computer programs and is identified in the patient.
provides such services as computer resource
allocation, job control, input/output control,

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 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 38 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
and file management in a computer system.
GUI PC SOFTWARE A1104 Problem associated with software, firmware, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FROZEN and/or hardware elements that control the clinical symptoms or a change in symptoms relation to the adverse event.
execution of computer programs and is identified in the patient.
provides such services as computer resource
allocation, job control, input/output control,
and file management in a computer system.
GUI PC TREATMENT A1104 Problem associated with software, firmware, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
INTERRUPTED and/or hardware elements that control the clinical symptoms or a change in symptoms relation to the adverse event.
execution of computer programs and is identified in the patient.
provides such services as computer resource
allocation, job control, input/output control,
and file management in a computer system.
HEAD-BLADE DOES A170102 A component required for the proper E2403 No patient involvement or, no observable F26 No apparent harm occurred in
NOT FIT INTO HEAD functioning of the device is not compatible clinical symptoms or a change in symptoms relation to the adverse event.
with other components or subassemblies of is identified in the patient.
the device, thus compromising the intended
function of the device.
HEAD-BLADE STUCK A150301 Problem associated with the device or one E2403 No patient involvement or, no observable F26 No apparent harm occurred in
of its components failing to detach or clinical symptoms or a change in symptoms relation to the adverse event.
separate as intended. is identified in the patient.
HEAD- A1801 Problem associated with the undesired E2403 No patient involvement or, no observable F26 No apparent harm occurred in
CONTAMINATION introduction of impurities either chemical or clinical symptoms or a change in symptoms relation to the adverse event.
microbiological in nature, or of foreign is identified in the patient.
matter into or onto the device.
HEAD-DENTED DOOR A0401 Problem associated with undesired damage E2403 No patient involvement or, no observable F26 No apparent harm occurred in
or breakage of those materials used in the clinical symptoms or a change in symptoms relation to the adverse event.
device construction. is identified in the patient.
HEAD-IRREGULAR CUT A050702 Inability of the device to make an incision, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
pierce or open as intended. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
HEAD-MOVEMENT A0506 The motion of the device is prevented or E2403 No patient involvement or, no observable F26 No apparent harm occurred in
restricted. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
HEAD-SCRATCHED A0401 Problem associated with undesired damage E2403 No patient involvement or, no observable F26 No apparent harm occurred in

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 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 39 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
or breakage of those materials used in the clinical symptoms or a change in symptoms relation to the adverse event.
device construction. is identified in the patient.
HEAD-WILL NOT FIT A0202 Problem associated with a device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
PROPERLY component having flaws of dimensional clinical symptoms or a change in symptoms relation to the adverse event.
deviations greater than acceptable for the is identified in the patient.
intended use.
HEAD-WORN OUT A0405 Problem associated with a undesired change E2403 No patient involvement or, no observable F26 No apparent harm occurred in
in the chemical structure, physical clinical symptoms or a change in symptoms relation to the adverse event.
properties, or appearance in the materials is identified in the patient.
that are used in the device construction.
HUMIDITY IS TOO A10 Problem associated with the device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
HIGH / LOW producing unintended temperatures. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
HV FAILURE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
HW/VERIFIC. CHECK A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
NOT PASSED characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
IMPROPER FIT A0202 Problem associated with a device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
component having flaws of dimensional clinical symptoms or a change in symptoms relation to the adverse event.
deviations greater than acceptable for the is identified in the patient.
intended use.
INADEQUATE A09 Problem associated with any deviation from E21 Procedural Complications F24 There is not yet enough
TREATMENT RESULT the documented specifications of the device information available to classify
that relate to the end result, data, or test the health impact.
results provided by the device.
INCORRECTLY A2101 Problem associated with the written, printed E2403 No patient involvement or, no observable F26 No apparent harm occurred in
LABELED PRODUCT or graphic material accompanying or affixed clinical symptoms or a change in symptoms relation to the adverse event.
to the device or any of its packaging. This is identified in the patient.
includes verbal instructions relating to
identification, technical description, and
usage provided by the device
manufacturers. Problems can include but are
not limited to this material being unclear,

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 40 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
missing, worn out, incorrect or inaccurate.
INSTABLE LASER A090403 Problem associated with the energy output E2403 No patient involvement or, no observable F26 No apparent harm occurred in
CONDITIONS from the device being inconsistent over clinical symptoms or a change in symptoms relation to the adverse event.
time. is identified in the patient.
INSTABLE/WRONG A090403 Problem associated with the energy output E2403 No patient involvement or, no observable F26 No apparent harm occurred in
SHOT FREQUENCY from the device being inconsistent over clinical symptoms or a change in symptoms relation to the adverse event.
time. is identified in the patient.
IRREGULAR CUT A050702 Inability of the device to make an incision, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
pierce or open as intended. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
JOYSTICK FUNCTION A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
LASER DOES NOT A0505 Problem associated with the device not E2403 No patient involvement or, no observable F26 No apparent harm occurred in
SHOOT discharging as intended. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
LASER HEAD A0505 Problem associated with the device not E2403 No patient involvement or, no observable F26 No apparent harm occurred in
AMPLIFIER DOES NOT discharging as intended. clinical symptoms or a change in symptoms relation to the adverse event.
WORK is identified in the patient.
LASER HEAD A0505 Problem associated with the device not E2403 No patient involvement or, no observable F26 No apparent harm occurred in
DEFECTIVE discharging as intended. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
LASER HEAD DOES A0505 Problem associated with the device not E2403 No patient involvement or, no observable F26 No apparent harm occurred in
NOT START discharging as intended. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
LASER HEAD ENERGY A0505 Problem associated with the device not E2403 No patient involvement or, no observable F26 No apparent harm occurred in
LOSS discharging as intended. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
LASER HEAD HAS A0505 Problem associated with the device not E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FLUCTUATIONS discharging as intended. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
LASER HEAD HV A0505 Problem associated with the device not E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILURE discharging as intended. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
LASER HEAD A050701 Problem associated with a circuit, E2403 No patient involvement or, no observable F26 No apparent harm occurred in

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 41 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
MISALIGNMENT equipment, or system whereby its functions clinical symptoms or a change in symptoms relation to the adverse event.
fail to be properly synchronized or its is identified in the patient.
relative positions properly oriented.
LASER HEAD A0505 Problem associated with the device not E2403 No patient involvement or, no observable F26 No apparent harm occurred in
OSZILLATOR DOES discharging as intended. clinical symptoms or a change in symptoms relation to the adverse event.
NOT is identified in the patient.
LASER HEAD POWER A0505 Problem associated with the device not E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILURE discharging as intended. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
LASER START ERROR A0505 Problem associated with the device not E2403 No patient involvement or, no observable F26 No apparent harm occurred in
discharging as intended. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
LASERARM IS A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
MISALIGNED characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
LCD BACKLIGHT NOT A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
WORKING characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
LEC CALIBRATION IS A08 Problem associated with the operation of E2403 No patient involvement or, no observable F26 No apparent harm occurred in
WRONG the device, related to its accuracy, and clinical symptoms or a change in symptoms relation to the adverse event.
associated with the calibration of the device. is identified in the patient.
LEC ERROR A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
LENS FAILURE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
LIFT TABLE FAILED A0506 The motion of the device is prevented or E2403 No patient involvement or, no observable F26 No apparent harm occurred in
restricted. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
LIGHT SOURCE FAILED A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
LIQUID IN VACUUM A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
SYSTEM characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 42 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
specified or delivered. is identified in the patient.
LOSS OF POWER A0708 Problem associated with the energy to E2403 No patient involvement or, no observable F26 No apparent harm occurred in
operate the device. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
LOSS OF VACUUM A1413 Problem associated with suction equipment, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
which may be a manual, electrical, vacuum clinical symptoms or a change in symptoms relation to the adverse event.
or pressure source operated to evacuate and is identified in the patient.
remove undesired substances (air, gas, fluid,
or particulates) via tubing and collection
bag.
LPS FAILURE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
LPS PINHOLES VALUES A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
ARE NOT FOUND characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
MAIN POWER SWITCH A0401 Problem associated with undesired damage E2403 No patient involvement or, no observable F26 No apparent harm occurred in
BROKEN or breakage of those materials used in the clinical symptoms or a change in symptoms relation to the adverse event.
device construction. is identified in the patient.
MICROSCOPE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
ILLUMINATION ERROR characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
MISSING A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
TREATMENTS characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
MONITOR IMAGE A0902 Problem with any deviation from the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
documented specifications of the device clinical symptoms or a change in symptoms relation to the adverse event.
that relate to visual feedback. e.g. the is identified in the patient.
display of information, images on a screen,
or output from the device.
MOTOR-BENT PIN- A0406 Problem associated with an undesired E2403 No patient involvement or, no observable F26 No apparent harm occurred in
AXIS material change in shape or property caused clinical symptoms or a change in symptoms relation to the adverse event.
by external forces. is identified in the patient.
MOTOR- A1801 Problem associated with the undesired E2403 No patient involvement or, no observable F26 No apparent harm occurred in
CONTAMINATION introduction of impurities either chemical or clinical symptoms or a change in symptoms relation to the adverse event.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 43 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
microbiological in nature, or of foreign is identified in the patient.
matter into or onto the device.
MOTOR-CORROSION A040502 Problem associated with the chemical or E2403 No patient involvement or, no observable F26 No apparent harm occurred in
electrochemical reaction between materials, clinical symptoms or a change in symptoms relation to the adverse event.
usually a metal and its environment that is identified in the patient.
produces a deterioration of the metal and its
properties.
MOTOR-CURRENT A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
MOTOR-DOES NOT A150101 Problem associated with the device failing to E2403 No patient involvement or, no observable F26 No apparent harm occurred in
ACTIVATE be activated including partial activation. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
MOTOR-DOES NOT A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
STOP characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
MOTOR-HOUSING A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
MOTOR-JAMMED A0506 The motion of the device is prevented or E2403 No patient involvement or, no observable F26 No apparent harm occurred in
restricted. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
MOTOR-WEAKNESS A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
OF SPRING PIN AXIS characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
MOTOR-WORN OUT A040507 Problem associated with material damage to E2403 No patient involvement or, no observable F26 No apparent harm occurred in
a surface, usually involving progressive loss clinical symptoms or a change in symptoms relation to the adverse event.
or displacement of material, due to relative is identified in the patient.
motion between that surface and a
contacting substance or substances.
NETWORK FAILED A1104 Problem associated with software, firmware, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
and/or hardware elements that control the clinical symptoms or a change in symptoms relation to the adverse event.
execution of computer programs and is identified in the patient.
provides such services as computer resource
allocation, job control, input/output control,

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 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 44 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
and file management in a computer system.
NO DATA FROM A13 Problem associated with the device sending E2403 No patient involvement or, no observable F26 No apparent harm occurred in
LASER RECEIVED or receiving signals or data. This includes clinical symptoms or a change in symptoms relation to the adverse event.
transmission among internal components of is identified in the patient.
the device to which the device is intended to
communicate.
NO DATA FROM ZDW A13 Problem associated with the device sending E2403 No patient involvement or, no observable F26 No apparent harm occurred in
RECEIVED or receiving signals or data. This includes clinical symptoms or a change in symptoms relation to the adverse event.
transmission among internal components of is identified in the patient.
the device to which the device is intended to
communicate.
NO MONITOR IMAGE A0902 Problem with any deviation from the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
documented specifications of the device clinical symptoms or a change in symptoms relation to the adverse event.
that relate to visual feedback. e.g. the is identified in the patient.
display of information, images on a screen,
or output from the device.
NO POWER A0708 Problem associated with the energy to E2403 No patient involvement or, no observable F26 No apparent harm occurred in
operate the device. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
NO SUCTION ON A1413 Problem associated with suction equipment, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
PATIENT which may be a manual, electrical, vacuum clinical symptoms or a change in symptoms relation to the adverse event.
or pressure source operated to evacuate and is identified in the patient.
remove undesired substances (air, gas, fluid,
or particulates) via tubing and collection
bag.
NO VACUUM A1413 Problem associated with suction equipment, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
which may be a manual, electrical, vacuum clinical symptoms or a change in symptoms relation to the adverse event.
or pressure source operated to evacuate and is identified in the patient.
remove undesired substances (air, gas, fluid,
or particulates) via tubing and collection
bag.
OCT CONTRAST A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
PROBLEMS characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
OCT DEFECTIVE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in

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 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 45 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
OCT MISALIGNED A050701 Problem associated with a circuit, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
equipment, or system whereby its functions clinical symptoms or a change in symptoms relation to the adverse event.
fail to be properly synchronized or its is identified in the patient.
relative positions properly oriented.
OCT NO PICTURE A0902 Problem with any deviation from the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
documented specifications of the device clinical symptoms or a change in symptoms relation to the adverse event.
that relate to visual feedback. e.g. the is identified in the patient.
display of information, images on a screen,
or output from the device.
OCT STRONG A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
REFLEXES characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
OPERATING SYSTEM A1104 Problem associated with software, firmware, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED and/or hardware elements that control the clinical symptoms or a change in symptoms relation to the adverse event.
execution of computer programs and is identified in the patient.
provides such services as computer resource
allocation, job control, input/output control,
and file management in a computer system.
ORBSCAN A13 Problem associated with the device sending E2403 No patient involvement or, no observable F26 No apparent harm occurred in
COMMUNICATION or receiving signals or data. This includes clinical symptoms or a change in symptoms relation to the adverse event.
LOST transmission among internal components of is identified in the patient.
the device to which the device is intended to
communicate.
ORBSCAN FAILURE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
ORBSCAN HEAD A0506 The motion of the device is prevented or E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FUNCTION FAILED restricted. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
OSZILATOR DOES NOT A150101 Problem associated with the device failing to E2403 No patient involvement or, no observable F26 No apparent harm occurred in
START be activated including partial activation. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
PARTICLE A040103 Problem associated with small pieces of the E2403 No patient involvement or, no observable F26 No apparent harm occurred in

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 46 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
device breaking off unexpectedly. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
PC BOOT ERROR A1104 Problem associated with software, firmware, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
and/or hardware elements that control the clinical symptoms or a change in symptoms relation to the adverse event.
execution of computer programs and is identified in the patient.
provides such services as computer resource
allocation, job control, input/output control,
and file management in a computer system.
PC PERIPHERAL A1104 Problem associated with software, firmware, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED and/or hardware elements that control the clinical symptoms or a change in symptoms relation to the adverse event.
execution of computer programs and is identified in the patient.
provides such services as computer resource
allocation, job control, input/output control,
and file management in a computer system.
PMX BOX FAILED A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
PRINTER NO A13 Problem associated with the device sending E2403 No patient involvement or, no observable F26 No apparent harm occurred in
COMMUNICATION or receiving signals or data. This includes clinical symptoms or a change in symptoms relation to the adverse event.
transmission among internal components of is identified in the patient.
the device to which the device is intended to
communicate.
PROGRAM GOT A1103 Problem associated with execution problems E2403 No patient involvement or, no observable F26 No apparent harm occurred in
TERMINATED relating to program or algorithm. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
PROGRAM OPTION A1103 Problem associated with execution problems E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED relating to program or algorithm. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
PSU MOVEMENT A0506 The motion of the device is prevented or E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILURE restricted. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
PSU PLUME A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
INTERLOCK ERROR characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
PSU TURBINE FAILED A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in

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 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 47 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
PSU TURBINE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
INTERLOCK ERROR characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
RAIL ASC ERROR A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
RAIL CUTTING LENS IS A1801 Problem associated with the undesired E2403 No patient involvement or, no observable F26 No apparent harm occurred in
DIRTY introduction of impurities either chemical or clinical symptoms or a change in symptoms relation to the adverse event.
microbiological in nature, or of foreign is identified in the patient.
matter into or onto the device.
RAIL CUTTING LENS IS A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
NOT FIX characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
RAIL DEFECTICE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
RAIL ELECTRICAL A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILURE characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
RAIL INTERLOCK A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
ERROR characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
RAIL LPS FAILURE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
RAIL OPTIC FAILURE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
RAIL SCANNER A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILURE characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
RAIL SHUTTER A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILURE characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.

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 >
CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 48 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
specified or delivered. is identified in the patient.
REMOTE DATABASE A13 Problem associated with the device sending E2403 No patient involvement or, no observable F26 No apparent harm occurred in
ACCESS FAILED or receiving signals or data. This includes clinical symptoms or a change in symptoms relation to the adverse event.
transmission among internal components of is identified in the patient.
the device to which the device is intended to
communicate.
REMOTE TO LASER A13 Problem associated with the device sending E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED or receiving signals or data. This includes clinical symptoms or a change in symptoms relation to the adverse event.
transmission among internal components of is identified in the patient.
the device to which the device is intended to
communicate.
REMOTE TO ZDW A13 Problem associated with the device sending E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED or receiving signals or data. This includes clinical symptoms or a change in symptoms relation to the adverse event.
transmission among internal components of is identified in the patient.
the device to which the device is intended to
communicate.
RESTORE-PROCESS A1107 Event in which data (charting, orders, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED results) is not correctly stored, transferred, clinical symptoms or a change in symptoms relation to the adverse event.
updated, or displayed. is identified in the patient.
RESULT SCREEN A0902 Problem with any deviation from the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
documented specifications of the device clinical symptoms or a change in symptoms relation to the adverse event.
that relate to visual feedback. e.g. the is identified in the patient.
display of information, images on a screen,
or output from the device.
ROBOTIC-ARM A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
POSITION FAILED characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
RT PC ERROR A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
SC3 CLOSING OR A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
OPENING PROBLEMS characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
SC3 CONTAMINATION A1801 Problem associated with the undesired E2403 No patient involvement or, no observable F26 No apparent harm occurred in
introduction of impurities either chemical or clinical symptoms or a change in symptoms relation to the adverse event.

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BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 49 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
microbiological in nature, or of foreign is identified in the patient.
matter into or onto the device.
SC3 MATERIAL FAULT A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
SC3 PARTICLE A1801 Problem associated with the undesired E2403 No patient involvement or, no observable F26 No apparent harm occurred in
introduction of impurities either chemical or clinical symptoms or a change in symptoms relation to the adverse event.
microbiological in nature, or of foreign is identified in the patient.
matter into or onto the device.
SC3 PI4 DOCKING A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
PROBLEM characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
SC3 SUCTION LOSS A1413 Problem associated with suction equipment, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
which may be a manual, electrical, vacuum clinical symptoms or a change in symptoms relation to the adverse event.
or pressure source operated to evacuate and is identified in the patient.
remove undesired substances (air, gas, fluid,
or particulates) via tubing and collection
bag.
SCANNER FAILURE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
SCANNER A10 Problem associated with the device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
TEMPERATURE producing unintended temperatures. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
SERVER NOT A1301 Problem associated with a failure of the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
REACHABLE device to read a signal for interpretation or clinical symptoms or a change in symptoms relation to the adverse event.
measurement. is identified in the patient.
SHARED T-DRIVE A1301 Problem associated with a failure of the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
MISSING device to read a signal for interpretation or clinical symptoms or a change in symptoms relation to the adverse event.
measurement. is identified in the patient.
SHEERFORCE FAILURE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
SHEERFORCE SENSORS A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
DEFECTIVE characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 50 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
specified or delivered. is identified in the patient.
SHELF LIFE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
SHUTTER FAILURE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
SOFTWARE CONFLICT A1102 Problem associated with the requirement E2403 No patient involvement or, no observable F26 No apparent harm occurred in
for software to fulfill its function within an clinical symptoms or a change in symptoms relation to the adverse event.
intended use or application. is identified in the patient.
SOFTWARE FROZEN A1102 Problem associated with the requirement E2403 No patient involvement or, no observable F26 No apparent harm occurred in
for software to fulfill its function within an clinical symptoms or a change in symptoms relation to the adverse event.
intended use or application. is identified in the patient.
STRANGE NOISE A0508 Problem associated with any unintended E2403 No patient involvement or, no observable F26 No apparent harm occurred in
sound which emanates from the device (for clinical symptoms or a change in symptoms relation to the adverse event.
example, squeaking from two parts rubbing is identified in the patient.
together or buzzing sounds from electrical
components).
SUCTION LOSS ON A1413 Problem associated with suction equipment, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
CONE which may be a manual, electrical, vacuum clinical symptoms or a change in symptoms relation to the adverse event.
or pressure source operated to evacuate and is identified in the patient.
remove undesired substances (air, gas, fluid,
or particulates) via tubing and collection
bag.
SURFACE DEFECT A0406 Problem associated with an undesired E2403 No patient involvement or, no observable F26 No apparent harm occurred in
material change in shape or property caused clinical symptoms or a change in symptoms relation to the adverse event.
by external forces. is identified in the patient.
TEMPERATURE IS TOO A10 Problem associated with the device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
HIGH / LOW producing unintended temperatures. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
TOUCH SCREEN A0902 Problem with any deviation from the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED documented specifications of the device clinical symptoms or a change in symptoms relation to the adverse event.
that relate to visual feedback. e.g. the is identified in the patient.
display of information, images on a screen,
or output from the device.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 51 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
TREATMENT A110303 Problem associated with the failure of a E2403 No patient involvement or, no observable F26 No apparent harm occurred in
INTERRUPTED program or algorithm to execute. clinical symptoms or a change in symptoms relation to the adverse event.
Sudden/unexpected interruption to a is identified in the patient.
program's execution.
TREATMENTCARD A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
TUBING DIFFICULT TO A12 Problem associated with linking of the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
CONNECT AND device and/or the functional units set up to clinical symptoms or a change in symptoms relation to the adverse event.
DISCONNECT provide means for a transfer of liquid, gas, is identified in the patient.
electricity or data.
TUBING LEAKY A0504 Problem associated with the escape of a E2403 No patient involvement or, no observable F26 No apparent harm occurred in
liquid, gas or radiation from the vessel or clinical symptoms or a change in symptoms relation to the adverse event.
container in which it is housed. is identified in the patient.
UNIT STOPPED A0506 The motion of the device is prevented or E2403 No patient involvement or, no observable F26 No apparent harm occurred in
DURING THE PASS restricted. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
UPS DOES NOT A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
CHARGE characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
UPS IS EMPTY A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
USER ANNOYANCE A22 Problem associated with an act or omission E2403 No patient involvement or, no observable F26 No apparent harm occurred in
of an act that has a different result than that clinical symptoms or a change in symptoms relation to the adverse event.
intended by the manufacturer or expected is identified in the patient.
by the operator.
VACCUM TUBE IS A0401 Problem associated with undesired damage E2403 No patient involvement or, no observable F26 No apparent harm occurred in
BROKEN or breakage of those materials used in the clinical symptoms or a change in symptoms relation to the adverse event.
device construction. is identified in the patient.
VACUUM DEFECTIVE A1413 Problem associated with suction equipment, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
which may be a manual, electrical, vacuum clinical symptoms or a change in symptoms relation to the adverse event.
or pressure source operated to evacuate and is identified in the patient.
remove undesired substances (air, gas, fluid,
or particulates) via tubing and collection

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 52 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
bag.
VACUUM FAILURE A1413 Problem associated with suction equipment, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
which may be a manual, electrical, vacuum clinical symptoms or a change in symptoms relation to the adverse event.
or pressure source operated to evacuate and is identified in the patient.
remove undesired substances (air, gas, fluid,
or particulates) via tubing and collection
bag.
VACUUM LOSS A1413 Problem associated with suction equipment, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
which may be a manual, electrical, vacuum clinical symptoms or a change in symptoms relation to the adverse event.
or pressure source operated to evacuate and is identified in the patient.
remove undesired substances (air, gas, fluid,
or particulates) via tubing and collection
bag.
VACUUM PUMP IS A0401 Problem associated with undesired damage E2403 No patient involvement or, no observable F26 No apparent harm occurred in
BROKEN or breakage of those materials used in the clinical symptoms or a change in symptoms relation to the adverse event.
device construction. is identified in the patient.
VACUUM SWITCHED A1413 Problem associated with suction equipment, E2403 No patient involvement or, no observable F26 No apparent harm occurred in
OFF which may be a manual, electrical, vacuum clinical symptoms or a change in symptoms relation to the adverse event.
or pressure source operated to evacuate and is identified in the patient.
remove undesired substances (air, gas, fluid,
or particulates) via tubing and collection
bag.
VACUUM TUBE IS A0401 Problem associated with undesired damage E2403 No patient involvement or, no observable F26 No apparent harm occurred in
BROKEN or breakage of those materials used in the clinical symptoms or a change in symptoms relation to the adverse event.
device construction. is identified in the patient.
VIDEO CAMERA A0902 Problem with any deviation from the E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILURE documented specifications of the device clinical symptoms or a change in symptoms relation to the adverse event.
that relate to visual feedback. e.g. the is identified in the patient.
display of information, images on a screen,
or output from the device.
WARNING MESSAGE A16 Problem associated with any deviations from E2403 No patient involvement or, no observable F26 No apparent harm occurred in
the documented specifications of the device clinical symptoms or a change in symptoms relation to the adverse event.
that relate to the implemented and is identified in the patient.
inherited design features specific to devices
used for reducing risks to patient or

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BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 53 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
caregiver or maintaining risks within
specified levels.
WEAR A040507 Problem associated with material damage to E2403 No patient involvement or, no observable F26 No apparent harm occurred in
a surface, usually involving progressive loss clinical symptoms or a change in symptoms relation to the adverse event.
or displacement of material, due to relative is identified in the patient.
motion between that surface and a
contacting substance or substances.
WIRELESS A13 Problem associated with the device sending E2403 No patient involvement or, no observable F26 No apparent harm occurred in
CONNECTION FAILED or receiving signals or data. This includes clinical symptoms or a change in symptoms relation to the adverse event.
transmission among internal components of is identified in the patient.
the device to which the device is intended to
communicate.
WRONG A090811 The device does not provide or display a E2403 No patient involvement or, no observable F26 No apparent harm occurred in
MEASUREMENTS valid reading. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.
ZDW ACCESS FAILED A1101 Problem associated with the deviations from E2403 No patient involvement or, no observable F26 No apparent harm occurred in
documented system specifications that clinical symptoms or a change in symptoms relation to the adverse event.
affects overall system performance and/or is identified in the patient.
the performance of an individual device
connected to that system.
ZRS-SERVER BOOT A1101 Problem associated with the deviations from E2403 No patient involvement or, no observable F26 No apparent harm occurred in
ERROR documented system specifications that clinical symptoms or a change in symptoms relation to the adverse event.
affects overall system performance and/or is identified in the patient.
the performance of an individual device
connected to that system.
ZRS-SERVER DOWN A1101 Problem associated with the deviations from E2403 No patient involvement or, no observable F26 No apparent harm occurred in
documented system specifications that clinical symptoms or a change in symptoms relation to the adverse event.
affects overall system performance and/or is identified in the patient.
the performance of an individual device
connected to that system.
ZYOPTIX-NETWORK A1101 Problem associated with the deviations from E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FAILED documented system specifications that clinical symptoms or a change in symptoms relation to the adverse event.
affects overall system performance and/or is identified in the patient.
the performance of an individual device
connected to that system.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 54 of 55
Effects) for Surgical

REFRACTIVE Annex A Annex A Annex Annex E Annex Annex F

Complaint Reason Device Problem Definition E Clinical Symptoms Definition F Health Impact Definition
ZYWAVE FAILURE A0201 Problem associated with an inherent device E2403 No patient involvement or, no observable F26 No apparent harm occurred in
characteristic that is not satisfactory as clinical symptoms or a change in symptoms relation to the adverse event.
specified or delivered. is identified in the patient.
ZYWAVE HEAD A0506 The motion of the device is prevented or E2403 No patient involvement or, no observable F26 No apparent harm occurred in
FUNCTION FAILED restricted. clinical symptoms or a change in symptoms relation to the adverse event.
is identified in the patient.

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

BAUSCH + LOMB 12.1.13-GREF-5

Global Reference Document Revision: 3
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 55 of 55
Effects) for Surgical

Revisions
Rev: 3 Author: Tes Proud CR-000351507

Description of Changes: ▪ Add new complaint reasons:

o Cataract – Heat Indicator/Received Overheated
o IAVP/Synergetics – Cybersecurity Issue
▪ Remove Solta categories
Implementation Instructions: Upon Document Approval

Rev: 2 Author: Tes Proud CR-000290448

Description of Changes: ▪ Update link to IMDRF website.

▪ Code updates for newly published IMDRF codes and per
system mapping.
▪ Add Refractive and Synergetics categories.

Implementation Instructions: Upon Document Approval

Rev: 1 Author: Tes Proud CR-000260376

Description of Changes: New document

Implementation Instructions: Upon Document Approval

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CONTROLLED DOCUMENT 12.1.13-GREF-5 Status: Effective Effective Date: 07/Nov/2022

CONTROLLED DOCUMENT
SIGNATURE PAGE
Document Name :REF-000258685

Document Title :IMDRF Codes Annexes A, E and F (Problem and Health Effects) for
Surgical

Document ID :12.1.13-GREF-5

Signed By Date (GMT) Justification

Garrett Tricia M 07/Nov/2022 Quality Approval

12:51:35

Antypenko Lina 26/Oct/2022 Functional Approval

19:37:21

Proud Tes 26/Oct/2022 Author Confirmation

19:53:29

Graham Meredith 31/Oct/2022 Functional Approval

22:13:17

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