| TGA Action ID |
RC-2026-RN-00403-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Iris Retractor MST/ MAL-1001 – Malyugin Ring 2.0 6.25mm
Lot Number: 206602
Expiry Date: 30/05/2028 |
| ARTG Number |
279045 |
| Unique Device Identifier (UDI) |
10844685006127 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There was one report of a Malyugin Ring exhibiting deformation during use, including bent struts and distorted scrolls. This prevented full engagement of the scrolls with the iris edge, resulting in inadequate fixation and device instability. The partially engaged, misshapen scrolls generated frictional forces on the iris during manipulation, leading to damage to the patient’s eye. |
| Instructions for Customers/Users |
Customers are to:
- Discard any faulty device identified and use an alternative device to mitigate the risk of harm if the device appears or performs abnormally.
- Inspect affected stock immediately and follow the instructions provided in the customer letter to reconcile this recall.
This action has been closed out on 04/08/2026 |
| Action Commencement Date |
27/05/2026 |
| Responsible Entity |
|
| Contact Information |
(08) 6275 7820 - Lucinda Brooks, IQ Medical |