2023-08-25T05:22:17
Recall detail
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 /
System for Australian Recall Actions
Type of Producti
Medical Device
TGA Recall Referenceii
RC-2023-RN-00323-1
Product
Name/Descriptioniii HOYA Vivinex iSert Toric IOLs
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
Classificationv Class II
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
Instructionsx HOYA Surgical Optics ask customers to place all impacted devices on hold in their
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
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