W900102062 - I - Lotfb - Us 2
W900102062 - I - Lotfb - Us 2
W900102062 - I - Lotfb - Us 2
HydraGlyde* for Astigmatism, AIR OPTIX* AQUA Multifocal, AIR OPTIX* plus HydraGlyde* Multifocal, W900127042
O2OPTIX* (lotrafilcon B) Soft Contact Lenses
IMPORTANT: This package insert is effective as of March 2018 and applicable to the lotrafilcon B contact lenses described below. Please read carefully and keep this information for future use. This package insert is intended for the eye care
professional, but should be made available to patients upon request. The eye care professional should provide the patient with appropriate instructions that pertain to the patient’s prescribed lenses. Copies of this package insert are available
without charge from Alcon by calling Customer Service at 1-800-241-5999 or download from our website at www.alcon.com. Alcon also makes available a Patient Instruction Booklet, which is recommended to be given to patients.
CAUTION: Federal law (United States) restricts this device to sale by or on WARNINGS • The eye care professional should be consulted about wearing lenses during
the order of a licensed eye care professional. Advise patients of the following warnings pertaining to contact lens wear: water sports and water related activities. Exposure to water while wearing
PRODUCT DESCRIPTION • Serious eye injury, scarring of the cornea, and loss of vision may contact lenses in activities such as swimming, water skiing, and hot tubs
AIR OPTIX* AQUA, AIR OPTIX* plus HydraGlyde*, AIR OPTIX* for result from problems associated with wearing contact lenses and may increase the risk of ocular infection, including but not limited to
Astigmatism, AIR OPTIX* plus HydraGlyde* for Astigmatism, AIR OPTIX* using contact lens care products. To reduce these risks, emphasize to Acanthamoeba keratitis.
AQUA Multifocal, AIR OPTIX* plus HydraGlyde* Multifocal and O2OPTIX* the patient the need for strict compliance with the lens care regimen • Eye irritation, infection, or lens damage may result if cosmetics, lotion, soap,
(lotrafilcon B) soft contact lenses are made of a lens material that is including hand washing, proper lens disinfection, cleaning of the lens cream, hairspray, deodorant, aerosol products or foreign particles come in
approximately 33% water and 67% lotrafilcon B, a fluoro-silicone containing case, wearing restrictions, wearing schedules, and follow-up visit contact with lenses.
hydrogel which is surface treated. Lenses contain the color additive copper schedules. • Never allow contact lenses to come into contact with non-sterile liquids
phthalocyanine, a light blue handling tint, to make them easier to see when (including tap water and saliva) as microbial contamination can occur, which
handling. • Eye problems, including corneal ulcers, can develop rapidly and lead may lead to permanent eye damage.
to loss of vision. Instruct patients at the dispensing visit and • Do not share lenses with anyone as this may spread micro-organisms which
• Lens Properties: subsequent visits to immediately remove their lenses and promptly could result in serious eye health problems.
o Refractive Index (hydrated): 1.42 contact their eye care professional if they should experience eye • Environmental fumes, smoke, and vapors should be avoided in order to
o Light Transmittance: ≥ 96% (@ 610 nm, -1.00D) discomfort, foreign body sensation, excessive tearing, vision changes, reduce the chance of lens contamination or physical trauma to the cornea.
o Oxygen Permeability (Dk): 110 x 10-11 (cm2/sec) (ml O2 /ml x mm Hg), redness of the eye or other problems with their eyes. • Lenses should be disposed of and replaced according to the eye care
measured at 35 °C (intrinsic Dk-Coulometric method) professional’s recommendations.
o Water Content: 33% by weight in normal saline • Non-compliance with the manufacturer’s labeled lens care
instructions may put the patient at significant risk of developing a • Note the correct lens power for each eye to prevent getting them mixed up.
• Lens Parameters serious eye infection. • Always keep a supply of replacement lenses on hand or have back-up
o Diameter Range: 13.0 to 15.0 mm spectacles available.
• Non-sterile liquids (i.e., tap water, distilled water, homemade saline • Do not use lenses beyond the expiration date.
o Power Range: -20.00 to +20.00D solution, or saliva) should NOT be used as a substitute for any
o Base Curve Range: 8.0 to 9.2 mm component in the lens care process. The use of tap and distilled water Solution Precautions:
• Lens Parameters Available1 has been associated with Acanthamoeba keratitis, a corneal infection • Eye injury due to irritation or infection may result from lens contamination. To
AIR OPTIX* AQUA and O2OPTIX* contact lenses (spherical): that is resistant to treatment and cure. reduce the risk of contamination, review the appropriate manufacturer’s
• Smoking increases the risk of corneal ulcers for contact lens users, labeled lens care instructions with the patient (see the LENS CARE
• Chord Diameter: 14.2 mm DIRECTIONS section).
• Center Thickness: 0.08 mm @ -3.00D (varies with power) especially when lenses are worn overnight or while sleeping.3,4
• Only use fresh, unexpired lens care solutions recommended for use with soft
• Base Curve: 8.6 mm • The risk of microbial keratitis (a serious eye infection) has been contact lenses and follow directions in the product package inserts.
• Powers: shown to be greater among users of extended wear lenses than • If a lens is exposed to air while off the eye it may become dry, brittle, and
o Minus Powers: -0.25 to -8.00D (0.25D steps); -8.50D to -10.00D among users of daily wear lenses.3 The risk increases with the permanently damaged. If this should occur, the lens should be discarded and
(0.50D steps) number of consecutive days that the lenses are worn between replaced with a new one to avoid possible irritation or injury to the eye.
o Plus Powers: +0.25 to +6.00D (0.25D steps) removals, even with the first overnight use. Always keep the lenses completely immersed in the recommended storage
AIR OPTIX* plus HydraGlyde* contact lenses (spherical): solution when lenses are not being worn.
PRECAUTIONS • Do not use thermal (heat) disinfection and do not heat lens care products.
• Chord Diameter: 14.2 mm To prevent damage to the eyes or to the contact lenses, the following
• Center Thickness: 0.08 mm @ -3.00D (varies with power) • Saliva or anything other than the recommended solution for lubricating or
precautions should be taken: wetting lenses should not be used with the lenses.
• Base Curve: 8.6 mm Special Precautions for the Eye Care Professional:
• Powers: Due to the small number of patients enrolled in the clinical investigation of
o Minus Powers: -0.25 to -8.00D in 0.25D steps; -8.50 to -12.00D in Lens Case Precautions:
lenses, all refractive powers, design configurations, or lens parameters available • Contact lens cases can be a source of bacterial growth and require proper
0.50D steps in the lens material are not evaluated in significant numbers. Consequently
o Plus Powers: +0.25 to +6.00D (0.25D steps); +6.50 to +8.00D use, cleaning and replacement at regular intervals as recommended by the
when selecting an appropriate lens design and parameters, the eye care lens case manufacturer or eye care professional.
(0.50D steps) professional should consider all characteristics of the lens that can affect lens
AIR OPTIX* for Astigmatism2 and AIR OPTIX* plus HydraGlyde* for performance and ocular health, including oxygen permeability, central and Other Topics to Discuss with Patients
Astigmatism contact lenses (toric): peripheral thickness and optic zone diameter. • Periodic eye examinations are extremely important for contact lens wearers.
• Chord Diameter: 14.5 mm The potential impact of these factors on the patient’s ocular health should be Schedule and conduct appropriate follow-up examinations to determine
• Center Thickness: 0.102 mm @ -3.00D (varies with power) carefully weighed against the patient’s need for refractive correction; therefore ocular response. Alcon recommends that patients see their eye care
• Base Curve: 8.7 mm the continuing ocular health of the patient and lens performance on the eye professional at least once each year or as recommended by the eye care
• Powers: should be carefully evaluated on initial dispensing and monitored on an ongoing professional.
o Minus Powers: plano to -6.00D (0.25D steps); -6.50 to -10.00D basis by the prescribing eye care professional. • Certain medications may cause dryness of the eye, increased lens
(0.50D steps) awareness, lens intolerance, blurred vision, or visional changes. These
o Plus Powers: +0.25 to +6.00D (0.25D steps) The following patients may not be suitable candidates and/or may experience a include, but are not limited to antihistamines, decongestants, diuretics,
o Cylinder: -0.75, -1.25, -1.75, -2.25 higher rate of adverse effects associated with contact lens wear: muscle relaxants, tranquilizers and those for motion sickness. Caution
o Axis: Full circle, 10° steps • Patients with a history of non-compliance with contact lens care and patients using medications accordingly and prescribe proper remedial
disinfection regimen, wearing restrictions, wearing schedule or measures.
AIR OPTIX* AQUA Multifocal and AIR OPTIX* plus HydraGlyde* Multifocal follow-up visit schedule.
contact lenses: • Visual changes or changes in lens tolerance may occur during pregnancy or
• Patients who are unable or unwilling to understand or comply with any use of oral contraceptives. Caution patients accordingly
• Chord Diameter: 14.2 mm directions, warnings, precautions, or restrictions. Contributing factors
• Center Thickness: 0.08 mm @ -3.00D (varies with power) may include but are not limited to age, infirmity, other mental or Who Should Know That the Patient is Wearing Contact Lenses:
• Base Curve: 8.6 mm physical conditions, and adverse working or living conditions. • Patients should inform their health care professional that they are wearing
• Powers: • Fluorescein, a yellow dye, should not be used while the lenses are on the contact lenses.
o Minus Powers: plano to -10.00D (0.25D steps) patient’s eyes. The lenses absorb this dye and become discolored. Whenever • Patient should inform their employers that they are wearing contact lenses.
o Plus Powers: +0.25 to +6.00D (0.25D steps) fluorescein is used, the eyes should be flushed thoroughly with sterile saline Some jobs may require the use of eye protection equipment or may require
o LO, MED, HI ADD solution that is recommended for in eye use prior to inserting lenses. Avoid that contact lenses not be worn.
ACTIONS dispensing saline from an aerosol can directly into the eye.
When hydrated and placed on the cornea, ALCON* (lotrafilcon B) soft contact • Before leaving the eye care professional’s office, patients should be able to It is strongly recommended that patients be provided with a copy of the
lenses act as a refracting medium to focus light rays on the retina. promptly remove their lenses or should have someone else available who AIR OPTIX* AQUA, AIR OPTIX* plus HydraGlyde*, AIR OPTIX* for
can remove their lenses for them. Astigmatism, AIR OPTIX* plus HydraGlyde* for Astigmatism, AIR OPTIX*
INDICATIONS (Uses) • Eye care professionals should instruct the patient to remove the lenses AQUA Multifocal and AIR OPTIX* plus HydraGlyde* Multifocal soft contact
• AIR OPTIX* AQUA, AIR OPTIX* plus HydraGlyde*, and O2OPTIX* (lotrafilcon B) immediately if the eye becomes red or irritated. lens Patient Instruction Booklet available from Alcon and understands its
spherical soft contact lenses are indicated for the optical correction of refractive • Routine eye examinations are necessary to help assure the continued health contents prior to dispensing the lenses.
ametropia (myopia and hyperopia) in phakic or aphakic persons with of the patient’s eyes. Eye care professionals should make arrangements with
non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism the patient for appropriate follow-up visits. ADVERSE EFFECTS (Possible Problems)
that does not interfere with visual acuity. • Diabetics may have reduced corneal sensitivity and thus are more prone to Patients should be instructed to check eyes regularly to make sure they look
• AIR OPTIX* for Astigmatism and AIR OPTIX* plus HydraGlyde* for corneal injury and do not heal as quickly or completely as non-diabetics. well, feel comfortable and vision is clear. Potentially serious complications are
Astigmatism (lotrafilcon B) toric soft contact lenses are indicated for the optical • Visual changes or changes in lens tolerance may occur during pregnancy or usually accompanied by one or more of the following signs and symptoms:
correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic use of oral contraceptives. Caution patients accordingly. • Moderate to severe eye pain not relieved by removing the lens
persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism. • Patients who wear contact lenses to correct presbyopia may not achieve the • Feeling of something in the eye (foreign body sensation)
best correct visual acuity for either far or near vision. Vision requirements • Excessive watering or other eye secretions including mucopurulent
• AIR OPTIX* AQUA Multifocal and AIR OPTIX* plus HydraGlyde* Multifocal vary with the individual and should be considered when selecting the most discharge
(lotrafilcon B) soft contact lenses are indicated for the optical correction of appropriate type of lens for each patient. • Redness of the eyes
presbyopia, with or without refractive ametropia (myopia and hyperopia) in • Sensitivity to light (photophobia)
phakic or aphakic persons with non-diseased eyes who may require a reading Eye Care Professionals should carefully instruct patients about the • Burning, stinging, or itching or other pain associated with the eyes
addition of +3.00 diopters (D) or less and who may have up to approximately following care regimen and safety precautions: • Comfort is less compared to when the lens was first placed on eye
1.50 diopters (D) of astigmatism that does not interfere with visual acuity. • Poor visual acuity (reduced sharpness of vision)
Handling Precautions:
The lenses may be prescribed for daily wear or extended wear for up to 6 • Be sure that before leaving the eye care professional’s office the patient is • Blurred vision, rainbows or halos around objects
nights of continuous wear with removal for disposal, or cleaning and able to promptly remove lenses or have someone else available to remove • Feeling of dryness
disinfection (chemical, not heat) prior to reinsertion, as recommended by the them. These symptoms, if ignored, may lead to more serious complications.
eye care professional. • Good hygiene habits help promote safe and comfortable lens wear. Always WHAT TO DO IF A PROBLEM OCCURS
wash and rinse hands before handling lenses.
CONTRAINDICATIONS (Reasons Not to Use) • REMOVE A LENS IMMEDIATELY if an eye becomes red or irritated.
Patients should be instructed that if any of the above signs or symptoms occur,
DO NOT use lotrafilcon B contact lenses when any of the following exists: • Carefully follow the handling, insertion, removal, cleaning, disinfecting,
he or she should:
• Inflammation or infection of the anterior chamber of the eye • IMMEDIATELY REMOVE LENSES.
storing and wearing instructions in the Patient Instruction Booklet for the • If the discomfort or problem stops, then look closely at the lenses.
• Any active disease, injury or abnormality affecting the cornea, conjunctiva, lotrafilcon B soft contact lenses prescribed.
or eyelids that may be exaggerated by contact lens wear o If a lens is in any way damaged, DO NOT put it back on the eye. Replace
• Always handle lenses carefully. If a lens is dropped small particles or fibers
• Microbial infection of the eye may adhere to the lens surface which can irritate the eye. Lenses should be
with a new lens and consult the eye care professional.
• Inadequate tear film (dry eye) that interferes with contact lens wear o If a lens has dirt, an eyelash, or foreign body on it, or the problem stops
cleaned and disinfected prior to insertion or replaced with a sterile, fresh
• Corneal hypoesthesia (reduced corneal sensitivity) new lens.
and the lens appears undamaged, thoroughly clean, rinse and disinfect
• Use of any medication that is contraindicated or interferes with contact lens • Never use tweezers or other sharp objects such as fingernails to remove
the lens before reinsertion.
wear, including eye medications lenses from the lens container. Pour the lens onto the hand.
• If the above symptoms continue after removal or upon reinsertion of the lens,
• Any systemic disease that may be exacerbated by or interferes with safe remove the lens immediately, then promptly contact an eye care
contact lens wear, handling, and/or care Lens Wearing Precautions:
professional.
• Allergic reactions or ocular irritation of the ocular surfaces or adnexa that • Patients should never exceed the prescribed wearing schedule, regardless of
• The patient should be informed that a serious condition such as corneal ulcer
may be caused by or exaggerated by the wearing of contact lenses how comfortable the lenses feel. Doing so may increase the risk of adverse
(ulcerative keratitis), infection, corneal vascularization or iritis may be
• Allergy to an ingredient in a solution which must be used to care for the effects.
present. These conditions may progress rapidly and may lead to permanent
contact lenses • The lens should move freely on the eye at all times. If the lens sticks (stops
loss of vision. Less serious reactions such as abrasions, infiltrates and
• Patient history of recurring eye or eyelid infections, adverse effects moving) on the eye, follow the recommended directions in the CARE FOR A
bacterial conjunctivitis must be managed and treated properly to avoid more
associated with contact lens wear, intolerance or abnormal ocular response STICKING LENS section. If non-movement of the lens continues, the patient
serious complications.
to contact lens wear should be instructed to consult their eye care professional immediately.
• Additionally contact lens wear may be associated with ocular changes that
• If eyes become red or irritated require consideration of discontinuation or restriction of wear. These include,
but are not limited to, local or generalized corneal edema, epithelial complete regimen in accordance with the manufacturer’s instructions in the o Do not use saliva, tap water, homemade saline solution, distilled water, or
microcysts, epithelial staining, infiltrates, neovascularization, endothelial package inserts may contribute to problems (see the ADVERSE EFFECTS anything other than a recommended sterile solution indicated for the care
polymegethism, tarsal papillary changes, conjunctival injection or iritis. section) and/or result in the development of serious ocular complications and of soft lenses.
• Occasional dryness may be relieved by blinking fully several times or by the discussed in the WARNINGS section. o Do not reuse solutions.
use of contact lens rewetting drops that are approved for use with soft o Use only fresh solutions for each lens care step. Never add fresh solution
contact lenses. If dryness persists, consult your eye care professional. Disposable Wear: to old solution in the lens case.
• If a lens sticks (stops moving), apply several drops of a contact lens • No lens care is indicated, as lenses are discarded upon removal from the o Follow the manufacturer’s instructions for care of the lens case.
rewetting solution and wait until the lens begins to move freely on the eye. If eye. o Replace the lens case at regular intervals to help prevent case
this problem persists, consult your eye care professional. • Lenses should only be cleaned, rinsed and disinfected on an emergency contamination by microorganisms that can cause eye infection.
• If a lens decenters on the eye, it may be possible to recenter it by: basis when replacement lenses are not available. o Never use a hard (rigid) lens solution unless it is also indicated for use
o Closing your eyelids and gently massaging the lens into place, or with soft contact lenses. Corneal injury may result if hard (rigid) lens
o Looking in the direction of the lens and blinking gently, or Replacement Wear: solutions not indicated for use with soft lenses are used in the soft lens
o Gently pushing the off-centered lens onto the cornea with light finger • When removed between replacement periods lenses must be cleaned and care regimen.
pressure on the edge of the upper or lower eyelid. disinfected prior to reinsertion or be discarded and replaced with a fresh o Always keep the lenses completely immersed in the recommended
• If a lens tears in your eye, remove the pieces carefully by pinching them as lens. storage solution when the lenses are not being worn to avoid lens
you would for normal lens removal. If the lens pieces do not seem to remove dehydration.
easily, do not pinch the eye tissue. Rinse with saline. If this does not help, Basic Instructions for Lens Cleaning and Disinfection: o Unless specifically indicated in the labeling, do not alternate, change, or
contact the eye care professional for assistance. When lenses are dispensed, the eye care professional should recommend an mix lens care systems or solutions for any one pair of lenses. If in doubt
appropriate system of lens care and provide the patient with instructions as to solution suitability, consult the eye care professional.
ADVERSE EFFECTS REPORTING according to the package labeling.
If a patient experiences any serious adverse effects associated with the use of CARE FOR A STICKING LENS
lotrafilcon B contact lenses, please notify: Alcon Medical Safety, in the USA at The eye care professional should review the following instructions with the If the lens sticks (stops moving) or begins to dry on the eye, instruct the patient
1-800-757-9780. patient: to apply several drops of a recommended lubricating solution (used in
FITTING GUIDE AND PATIENT BOOKLET • Each time lenses are removed from the eye they must be properly cleaned, accordance with package labeling). The patient should wait until the lens begins
Conventional methods of fitting contact lenses apply to lotrafilcon B contact rinsed, and disinfected before reuse. If removed while the patient is away to move freely on the eye before attempting to remove it. If the lens continues to
lenses. For a detailed description of the fitting techniques, refer to the from lens care products, the lenses may not be reinserted, but should be stick, the patient should IMMEDIATELY consult the eye care professional.
AIR OPTIX* AQUA, AIR OPTIX* plus HydraGlyde*, AIR OPTIX* for stored until they can be cleaned, rinsed and disinfected. IN OFFICE USE OF TRIAL LENSES
Astigmatism, AIR OPTIX* plus HydraGlyde* for Astigmatism, AIR OPTIX* • Cleaning is necessary to remove mucus, film and contamination from the
Eye care professionals should educate contact lens technicians concerning
AQUA Multifocal and AIR OPTIX* plus HydraGlyde* Multifocal (lotrafilcon B) lens surface. Rinsing removes all traces of the cleaner and loosened debris. proper use of trial lenses.
contact lens Professional Fitting and Information Guide. Both the fitting guide Disinfecting is necessary to destroy remaining microorganisms.
Each contact lens is shipped sterile in a blister pack containing phosphate
and a Patient Instruction Booklet are available free of charge from: • Lenses must be cleaned, rinsed, disinfected and stored in accordance with buffered saline solution with or without additives. Hands should be thoroughly
Alcon Laboratories, Inc. the package labeling of the lens care products recommended by the eye care washed, rinsed and dried with a lint-free towel prior to handling a lens. In order
6201 South Freeway professional. Typical instructions for lens care products include the steps to ensure sterility, the blister pack should not be opened until immediately prior
Fort Worth, TX 76134-2099 USA presented below. IMPORTANT: Hydrogen Peroxide disinfecting solutions, such to use. For fitting and diagnostic purposes, the lenses should be disposed of
as CLEAR CARE* PLUS Cleaning & Disinfecting Solution, are not after a single use and not be re-used from patient to patient.
or by calling Alcon Customer Service in the USA at 1-800-241-5999. multi-purpose solutions. For hydrogen peroxide disinfecting solutions follow
the manufacturer’s instructions. EMERGENCIES
LENS WEAR AND REPLACEMENT SCHEDULES • Soaking and Storing Your Lenses: The patient should be informed that if chemicals of any kind (household
The wearing and replacement schedule should be determined by an eye care o Use only fresh contact lens care solution each time you soak (store) your products, gardening solutions, laboratory chemicals, etc.) are splashed into the
professional based on the patient’s individual needs and physiological lenses. eyes:
conditions. The eye care professional may recommend daily wear only or Warning: • Flush eyes immediately with fresh saline solution or tap water.
extended wear periods up to 6 nights. Not everyone can reach the maximum • Do not reuse or “top off” old solution left in your lens case since solution • Remove and discard lenses and immediately contact the eye care
wear time of 6 continuous nights. reuse reduces effective lens disinfection and could lead to severe professional or visit a hospital emergency room without delay.
Daily Wear (less than 24 hours, while awake) infection, vision loss or blindness. To “top-off” means to add fresh
solution to solution that has been sitting in your lens case. HOW SUPPLIED
• To avoid tendency of the daily wear patient to over wear the lenses initially, Each lens is provided in a foil-sealed plastic container containing buffered saline
stress the importance of adhering to a proper, initial wearing schedule. solution and is steam sterilized. The packaging saline may contain additives, as
Normal daily wear of lenses assumes a minimum of 6 hours of non-lens • Rub and Rinse Time: follows:
wear per 24 hour period. o Some lens care products require a rub and rinse step. If so, follow the • AIR OPTIX* for Astigmatism, O2OPTIX* contact lenses: Phosphate Buffered
• It may be advisable for patients who have never worn contact lenses lens care manufacturer’s instructions for solution quantity and rub and Saline (PBS)
previously to be given a wearing schedule that gradually increases wearing rinse time to reduce the risk of serious eye infections. • AIR OPTIX* AQUA, AIR OPTIX* AQUA Multifocal contact lenses: PBS with
time over a few days. This allows more gradual adaptation of the ocular o The amount of time you can store lenses before cleaning, rinsing, and 1% Copolymer 845 wetting agent
tissues to contact lens wear. disinfection steps need to be repeated will vary depending on the lens • AIR OPTIX* plus HydraGlyde*, AIR OPTIX* plus HydraGlyde* for
care product used. Astigmatism and AIR OPTIX* plus HydraGlyde* Multifocal contact lenses:
Extended Wear (greater than 24 hours, including while asleep): Warning: PBS with 0.2% VP/DMAEMA and 0.04% Polyoxyethylene-polyoxybutylene
• The eye care professional should establish an extended wear period up to 6 • Rub and rinse lenses for the recommended amount of time to help wetting agents
continuous nights that is appropriate for each patient. Once the lens is prevent serious eye infections.
removed, the patient’s eyes should have a rest period with no lens wear of • Never use water, saline solution, or rewetting drops to disinfect your The blister package is marked with the base curve, diameter, dioptric power,
overnight or longer, as recommended by the eye care professional. lenses. These solutions will not disinfect your lenses. Not using the cylinder and axis (where applicable), ADD power (where applicable),
• It is suggested that new contact lens wearers first be evaluated on a recommended disinfecting solution can lead to severe infection, vision manufacturing lot number, and expiration date.
daily wear schedule. If the patient is judged to be an acceptable loss or blindness. The package labeling may also contain a product code, as follows:
extended wear candidate, the eye care professional may determine an LFB110 [spherical lotrafilcon B in phosphate buffered saline (PBS)];
extended wear schedule based upon the response of the patient. • Discard Date for Lens Cleaning and Disinfecting Solutions LFB110c [spherical lotrafilcon B in PBS + Copolymer 845 (e.g., VP/DMAEMA)];
• See WARNINGS section for information about the relationship between o After opening, discard any remaining solution after the period LFB110e [spherical lotrafilcon B in PBS + Copolymer (e.g., VP/DMAEMA) +
wearing schedule and corneal complications. recommended by the lens care manufacturer. If using the lens care HydraGlyde];
products listed below, discard remaining solution as follows: LFB110-T (toric lotrafilcon B in PBS);
Lens Replacement • CLEAR CARE* PLUS Cleaning & Disinfecting Solution - 3 months LFB110-MF [(multifocal lotrafilcon B in PBS + Copolymer) (e.g., VP/DMAEMA)];
The replacement schedule is determined by the eye care professional based on after opening. LFB110-Te [toric lotrafilcon B in PBS + Copolymer (e.g., VP/DMAEMA) +
the patient’s individual needs and physiological conditions. Lenses should be • OPTI-FREE* PureMoist* Multi-Purpose Disinfecting Solution - 6 HydraGlyde];
discarded and replaced with a new pair each month, or more often, if months after opening. LFB110MFe [multifocal lotrafilcon B in PBS + Copolymer (e.g., VP/DMAEMA) +
recommended by the eye care professional. Warning: HydraGlyde].
LENS HANDLING INSTRUCTIONS • Using your lens care solution beyond the discard date could result in Lenses are supplied in cartons containing up to 12 individually sealed contact
• Always wash and rinse hands thoroughly and dry completely with a clean, contamination of the solution and can lead to severe infection, vision lenses.
lint-free towel before handling contact lenses. loss or blindness. The following may appear Symbol/ Description
• Do not use if blister package is damaged or not sealed completely. This may on the labels or cartons: Abbreviation
result in product contamination which can lead to a serious eye infection. The above instructions are typical for a lens cleaning product, however you must
always consult the instructions for the specific lens care product used. CAUTION: Federal law (United States) restricts this
• Shake the blister pack (containing a fresh new lens) gently prior to opening. device to sale by or on the order of a licensed eye care
• Remove the lens from the blister pack (or lens storage case for previously • Alcon recommends a chemical (not heat) method of disinfection such as professional.
worn lenses) by carefully pouring it onto the palm of the hand. CLEAR CARE* PLUS Cleaning & Disinfecting Solution or OPTI-FREE* Sterilized using steam
• Ensure the lens is right side out and that you have the correct lens for each PureMoist* Multi-purpose Disinfecting Solution.
• Use of an enzymatic cleaner is optional and may be recommended by the Use-by date
eye.
• Inspect the lenses prior to insertion. eye care professional if warranted. EXP Expiration date
• Do not insert damaged or unclean lenses. • Lens compatibility with an abrasive type cleaner such as OPTI-CLEAN* II Batch code
Daily Cleaner has not been tested and is not recommended. en Example of two letter language code (English)
Lens Insertion Instructions • Heat disinfection has not been tested and is not recommended. Do not use if blister package is damaged
• Wash and rinse hands thoroughly and dry completely with a clean, lint-free European conformity mark and Notified Body number
towel. Basic Instructions for the Lens Case
Contact lens care solutions and contact lens cases vary and have different Consult instructions for use
• Place a lens on the tip of your clean and dry right or left index finger. Place
the middle finger of the same hand close to lower eyelashes and pull down purposes and instructions for use. Some cases are intended exclusively for Caution
the lower eyelid. storing contact lenses (sometimes referred to as a lens flat pack or lens storage Authorized Representative in the European Community
• Use the fingers of the other hand to lift the upper eyelid. case), while others are specially designed to contain a neutralizing disc for use Manufacturer
• Place the lens directly on the eye (cornea) and gently roll finger away from with hydrogen peroxide cleaning and disinfecting systems. If not being worn on Packaging waste license sign
the lens. a daily disposable basis, lenses that have been cleaned and disinfected can be
stored in the unopened case for a period of time that varies depending on the DIA Diameter
• Look down and slowly release the lower lid.
• Look straight ahead and slowly release the upper lid. contact lens solution and lens case used. Always follow the instructions provided BC Base curve
• Blink gently. by the manufacturer for the lens care products used. PWR Power
• The eye care professional should instruct the patient on how to use the D Diopter (lens power)
Lens Removal Instructions recommended lens care solution(s) and lens case. Addition power
ADD
• Wash and rinse hands thoroughly, and dry completely with a clean, lint-free • Contact lens cases can be a source of bacterial growth and require proper
towel. MAX ADD Maximum effective addition power
cleaning, drying and replacement to avoid contamination or damage to
• Blink fully several times. lenses: LO Low
• While looking up, use the tip of the finger to slide the lens down onto the o Clean contact lens cases with an appropriate contact lens solution and MED Medium
white part of the eye. dry according to lens case instructions. Drying instructions, such as HI High
• Remove the lens by pinching gently between thumb and forefinger. Do not air-drying or wiping with lint-free towel, may vary depending on the lens L Left
pinch the eye tissue. case used. R Right
• If the lens is difficult to remove, instill a lubricating and rewetting drop and o Replace contact lens cases at least once every 3 months, or as
try again after several minutes. VP/DMAEMA Vinylpyrrolidone/Dimethylaminoethylmethacrylate
recommended by the lens case manufacturer.
• Never use tweezers, suction cups, sharp objects or finger nails to remove o Replace specially designed lens cases containing a neutralizing disc Date of preparation: March 2018
lenses from the lens container or your eyes. according to manufacturer directions, or sooner if cleaned and disinfected Alcon Laboratories, Inc. *a trademark of Novartis
lenses cause burning and stinging. 6201 South Freeway © 2016, 2018 Novartis
WATER ACTIVITES Fort Worth, TX 76134-2099 USA
Do not expose contact lenses to water while wearing them. Warning:
• Do not store your lenses or rinse your lens case with water or any W900127042-0318
Warning: U.S. Pat.: www.alconpatents.com
Water can harbor microorganisms that can lead to severe infection, vision non-sterile solution. Only use fresh disinfecting solution in order to avoid
contamination of your lenses or lens case. Use of non-sterile solution 1
Check for actual product availability, which may change over time.
loss or blindness. If lenses have been submersed in water when showering Manufacture of O2OPTIX* lenses discontinued 2014
or swimming, discard them and replace with a new pair. Ask the eye care can lead to severe infection, vision loss or blindness.
2
May also be labeled as O2OPTIX* for Astigmatism
professional for recommendations about wearing lenses during any activity
• To help avoid serious eye injury from contamination, the eye care 3
Cutter GR, Chalmers RL, Roseman M. The Clinical Presentation, Prevalence,
involving water. professional should review the following instructions with the patient: and Risk Factors of Focal Corneal Infiltrates in Soft Contact Lens Wearers. The
o Always wash, rinse and dry hands before handling the lenses. CLAO Journal. Jan 1996; 22 (1): 30-37.
LENS CARE DIRECTIONS o Use only fresh sterile solutions recommended for use with soft 4
Schein OD, Glynn RJ, Poggio EC, Seddon JM, Kenyon KR. The Relative Risk of
Patients must adhere to a recommended lens care regimen. Lenses must be (hydrophilic) contact lenses. When opened, sterile non-preserved Ulcerative Keratitis Among Users of Daily-Wear and Extended-Wear Soft
cleaned, rinsed and disinfected after removal and prior to reinsertion on the eye solutions must be discarded after the time specified in the label Contact Lenses. N Eng J Med. 1989; 321(12):773-83.
according to the instructions in the package inserts provided with the lens care directions.
products recommended by the eye care professional. Failure to follow the