| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00328-1 |
| Product Name/Description |
Labtician Ophthalmics Silicone Sleeve Retinal Implant
Reference Number: S3018
Lot Number: 22503
ARTG 337137
(Kevin Grundy (IBD) Pty Ltd - Scleral buckling device, non-bioabsorbable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
16/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
There is a discrepancy between the expiry date indicated on the outer packaging and the correct expiry date stated on the inner packaging. Specifically, the outer packaging displays an expiry date of 09/2030, while the correct expiry date is 08/2030, as indicated on the inner packaging.
This problem does not affect any other lots of Labtician Ophthalmics Retinal implants or any other Labtician Ophthalmics products.
This lot has been distributed to wholesalers since January 2024. |
| Recall Action |
Recall |
| Recall Action Instructions |
Distributor:
- Quarantine all affected products in inventory immediately.
- Cease distribution and use of the affected products.
- Contact customers and provide them with a copy of the customer letter informing of the problem and to return affected stock.
- A credit will be provided.
Hospitals/Clinics:
- Quarantine all affected products in inventory immediately.
- Cease use of the affected products.
- Return affected stock.
- No action is required on products already use. (There is no risk on products used).
- A credit will be provided. |
| Contact Information |
02 9261 0688 - Elizabeth Maney, Kevin Grundy (IBD) |