Central Drugs Standard Control Organization

Directorate General of Health Services

Ministry of Health and Family Welfare
Government of India
(Medical Devices and Diagnostics Division)
Email: [email protected]

Food & Drugs Administration Bhawan,

Kotla Road, New Delhi.
F.No. 29/Misc./03/2023-DC(134) Date: 08th May 2023

MEDICAL DEVICE ALERT

DEVICE

HOYA Vivinex Toric IOLs (Model Numbers: XY1AT2, XY1AT3, XY1AT4,

XY1AT5, XY1AT6, XY1AT7, XY1AT8 and XY1AT9)

Manufactured from June 2022 to January 2023 (List of affected batches in

India attached)
BACKGROUND

HOYA Surgical Optics is recalling HOYA Vivinex iSert Toric IOLs from a
specified manufacturing period (June 2022 to January 2023). Recall Action
Classification Class II, Recall Action Commencement Date 12.04.2023.

Reason for Recall

HOYA Surgical Optics is recalling HOYA Vivinex iSert Toric IOLs from a
specified manufacturing period (June 2022 to January 2023) and have
received customer’s complaints in Australia and Japan, with reports of
damage (such as scratches) and fragment adhesion on the IOL optic surface.
Following the initial investigation of returned samples, HOYA identified that
damage had occurred to the nozzle tip of the iSert injector during Toric IOL
implantation. This damage might have led to the reported scratches on the
optic surface and polypropylene (PP) resin fragments from inside the injector
tip to adhere to the IOL surface (PP adhesion).
FURTHER DETAILS & CONTACTS

Recall Action Notification for Hoya Vivinex isert Toric IOLs from Department of
Health, Therapeutics Goods Administration, Australian Government herewith
attached with this alert.
M/s. HOYA Medical India Pvt. Ltd.,
H-9, 2nd Floor, Block- B1, Mohan Co-operative Industrial Estate,
Mathura Road, South Delhi
New Delhi 110044 India
hoyasurgicaloptics.com
Page 1 of 1
Recall Action Notification
HOYA Vivinex iSert Toric IOLs

© Commonwealth of Australia 2023.

This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use
or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not
use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of
that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice,
all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way
(electronic or otherwise) without first being given specific written permission from the Commonwealth to do so.
Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic
Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <[email protected]>.
System for Australian Recall Actions

Important information on the System for Australian Recall Actions

The TGA publishes information about therapeutic goods supplied in the Australian market that have been
subject to a recall action in a publicly searchable database.
Recall action means action taken by the responsible entity (being the person who is responsible for taking the
recall action) to resolve a problem with therapeutic goods supplied in the Australian market that have, or may
potentially have, deficiencies relating to safety, quality, efficacy (performance) or presentation.
• Recall actions include: the permanent removal of therapeutic goods from supply in the market, the
taking of corrective action in relation to therapeutic goods (such as repair, modification, adjustment or
relabelling) and, in the case of medical devices that have been implanted into patients, the issuing of a
hazard alert containing information for health practitioners on how to manage patients.
• More information about Australian recall actions is available at <http://tga.gov.au/safety/recalls-about.htm>
• If you are taking a medicine, using a medical device or have had a medical device implanted into you,
that is the subject to a recall action, and you have any concerns you should seek advice from a health
professional. <http://www.healthdirect.org.au/>

About the release of this information

While reasonable care is taken to ensure that the information is an accurate record of recall actions that responsible
entities have reported to the TGA or of which the TGA has become aware, the TGA does not guarantee or warrant the
accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose.
To the fullest extent permitted by law, including but not limited to section 61A of the Therapeutic Goods Act 1989, the
TGA will not be liable for any loss, damage, cost or expense incurred in or arising by reason of any person relying on
this information.
The information contained in the SARA database is released under s 61(5C) of the Therapeutic Goods Act 1989.
Copyright restrictions apply to the System of Australian Recall actions (SARA) <http://tga.gov.au/about/website-
copyright.htm>.

Report generated 28/04/2023 1:14:39 AM Page 2 of 4

System for Australian Recall Actions

Recall detail

Type of Producti Medical Device

TGA Recall Referenceii RC-2023-RN-00323-1

Product HOYA Vivinex iSert Toric IOLs

Name/Descriptioniii

Model numbers: XY1AT2, XY1AT3, XY1AT4, XY1AT5, XY1AT6, XY1AT7, XY1AT8 and
XY1AT9

Manufactured from June 2022 to January 2023

ARTG 287542
(Designs for Vision Aust Pty Ltd - Lens, intraocular, posterior chamber)
Recall Action Leveliv Hospital
Recall Action Class II
Classificationv
Recall Action
Commencement Datevi 12/04/2023
Responsible Entityvii Designs for Vision Aust Pty Ltd
Reason / Issueviii HOYA Surgical Optics is recalling HOYA Vivinex iSert Toric IOLs from a specified
manufacturing period (June 2022 to January 2023) and have received customers
complaints in Australia and Japan, with reports of damage (such as scratches) and
fragment adhesion on the IOL optic surface. Following the initial investigation of returned
samples, HOYA identified that damage had occurred to the nozzle tip of the iSert injector
during Toric IOL implantation. This damage might have led to the reported scratches on
the optic surface and polypropylene (PP) resin fragments from inside the injector tip to
adhere to the IOL surface (PP adhesion).
Recall Actionix Recall
Recall Action HOYA Surgical Optics ask customers to place all impacted devices on hold in their
Instructionsx
inventory system and quarantine them for collection by a Designs For Vision
representative.
HOYA Surgical Optics notes that IOL explantation is not recommended, however it is
recommended that the patients involved, i.e., the cases where lenses with PP adhesion
have been left in the eye, be monitored for the need for any future medical treatment.
Contact Informationxi 1800 225 307 - Designs For Vision

Footnotes
i Type of Product: Medicine, Medical Device, or Biological
ii TGA Recall Reference: Unique number given by the TGA
iii Product Name/Description: Brand name (including active ingredient for medicines) and may include generic reference
for the kind of medical devices. Includes all necessary information such as affected: catalogue / model and / or batch /

Report generated 28/04/2023 1:14:39 AM Page 3 of 4

The TGA publishes Australian recall actions in a searchable database to ensure the public has access to information
about therapeutic products that have been recalled from the Australian market. If you are concerned about your health
or if you have experienced an adverse event please seek advice from a health professional as soon as possible.
Please read all the important information at the beginning of this report.
System for Australian Recall Actions

serial numbers.
iv Recall Action Level: The level to which the recall action is to be undertaken. This is based on the significance of the
risk and the channels through which the goods have been distributed. The recall action levels are / Wholesale /
Hospital / Retail / Consumer.
• Wholesale - includes wholesalers and state purchasing authorities.
• Hospital - includes nursing homes and institutions, hospital pharmacists, ambulance services, blood and tissue
banks and laboratories as well as wholesale as appropriate.
• Retail - includes retail pharmacists, medical, dental and other health care professionals as well as wholesale
and hospital as appropriate.
• Consumer - includes patients and consumers, as well as wholesale, hospital and retail levels as appropriate.
v Recall Action Classification**: Recall actions of therapeutic goods are classified based on the potential risk the
deficiency poses to patients / consumers. They are classified as Class I, Class II or Class III.
• Class I - A situation in which there is a reasonable probability that the use of, or exposure to, the deficient
therapeutic good(s) will cause serious adverse health consequences or death.
• Class II - A situation in which use of, or exposure to, the deficient therapeutic good(s) may cause temporary or
medically reversible adverse health consequences, or where the probability of serious adverse health
consequences is remote.
• Class III- A situation in which use of, or exposure to, the deficient therapeutic good(s) is not likely to cause
adverse health consequences.
vi Recall Action Commencement Date: The date the recall strategy and communication was agreed by the TGA.
vii Responsible Entity: Sponsor / Supplier / Importer responsible for the recall actions.
viii Reason / Issue: Reason for the recall action.
ix Recall Action**: Recall action is an action taken to resolve a problem with a therapeutic good already supplied in the
market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation.
There are four distinct recall actions – recall, product defect correction, hazard alert and product defect alert.
• Recall - The permanent removal of an affected therapeutic good from supply or use in the market.
• Product defect correction - Repair, modification, adjustment or re-labelling of a therapeutic good. The
corrective action may take place at the user's premises or any other agreed location.
• Hazard alert - Information issued to healthcare professionals about issues or deficiencies relating to an
implanted medical device or biological product and advice about the ongoing management of patients.
• Product defect alert - Information issued to raise awareness about issues or deficiencies for a therapeutic
good where a recall action will result in interruption of patient treatment or a medicine shortage, including advice
to reduce potential risks of using affected goods.
x Recall Action Instructions: What customers with affected goods should do.
xi Contact Information: Who the customer should contact for additional information and clarification regarding the recall
action.

** These definitions are applicable to the 2017 URPTG (Implemented from Jan 15 2018). Recall Action types and
Recall Action Classifications prior to 15 Jan 2018 can be found at:
https://www.tga.gov.au/sites/default/files/recalls-urptg-170412.pdf

Report generated 28/04/2023 1:14:39 AM Page 4 of 4

The TGA publishes Australian recall actions in a searchable database to ensure the public has access to information
about therapeutic products that have been recalled from the Australian market. If you are concerned about your health
or if you have experienced an adverse event please seek advice from a health professional as soon as possible.
Please read all the important information at the beginning of this report.