| TGA Action ID |
RC-2026-RN-00289-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
HOYA Vivinex iSert Toric intraocular lens (IOL)
Model Numbers: XY1AT2, XY1AT3, XY1AT4, XY1AT5, XY1AT6, XY1AT7, XY1AT8, XY1AT9
Multiple serial numbers. |
| ARTG Number |
464253 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The affected products may contain polypropylene (PP) particles from the injector that could adhere to the intraocular lens during implantation. In certain cases, this may result in implanted intraocular lens (IOL) with polypropylene (PP) adhesion remaining in the patient’s eye. |
| Instructions for Customers/Users |
For Customers
Please take the following actions immediately:
1. Confirm if affected products have been distributed to you by checking the Serial Numbers listed on the labels- an example of how to is in the customer letter
2. Immediately put impacted products on hold and physically segregate them.
3. Hand the “Dear Healthcare Professional Letter” to all surgeons who implanted the affected products
4. After receiving the Customer Reply Form in rh letter you will be contacted with detailed instructions for how to return products for replacement free of charge.
For Surgeons
1. If you have any affected stock on hand, please return it to place of purchase for a refund
2. Please refer to Appendix 1 for the Medical Recommendations in the customer letter which notes that IOL explantation is not recommended if no actual harm is identified.
This action has been closed out on 03/06/2026 |
| Action Commencement Date |
22/04/2026 |
| Responsible Entity |
|
| Contact Information |
0412 111 631 - HOYA Medical |