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