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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 iNova Pharmaceuticals Australia Pty Ltd
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