| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00520-1 |
| Product Name/Description |
EZ-Load Lens Delivery System
Model Number: EZ-28V
Lot Numbers: H672001 (expiry Nov 2017) and H674001 (expiry Dec 2017)
ARTG Number: 98258 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
iNova has identified an issue with two lots of the EZ-Load Lens Delivery System EZ-28V, an intraocular lens inserter used to insert SofPort intraocular lenses (IOLs). Some inserters have been found to have a hook-like flash located near the tip area. This flash catches the leading haptic causing a kink. Whilst mildly bent haptics can be restored to acceptable configuration intra-operatively using surgical instruments, a severely kinked haptic which cannot be restored can result in injury to the intraocular structures. |
| Recall Action |
Recall |
| Recall Action Instructions |
iNova is advising users to inspect their stock of EZ-Load Lens Delivery System (EZ-28V) immediately and quarantine any affected lots. iNova will arrange for stock collection and will issue credit for returned stock.
This action has been closed out on 21/09/2018 |
| Contact Information |
1800 251 150 - Bausch + Lomb Customer Service |