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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00366-1
Product Name/Description LaserEdge Knives

Multiple Product Codes and Lots

ARTG Number: 211586
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 10/03/2017
Responsible Entity iNova Pharmaceuticals Australia Pty Ltd
Reason/Issue iNova Pharmaceuticals (Australia) Pty Ltd (iNova) is conducting an urgent recall of 82 lots of 11 LaserEdge knife SKUs used in ophthalmic surgery due to an atypical number of dull blade complaints. If excessive force is required to push a dull blade through the cornea this may result in a sub-optimal incision. Uncontrolled penetration through the cornea may also result in injury to anterior segment structures.

Patients undergoing posterior segment surgery (e.g. vitrectomy) are at potential risk for suprachoroidal haemorrhage or retinal injury which, in rare instances, may be associated with permanent loss of vision. The likelihood of adverse events associated with dull blades is very low.
Recall Action Recall
Recall Action Instructions Customers are notified to inspect their stock immediately and quarantine affected stock of LaserEdge knives. iNova (Bausch + Lomb) will arrange for the stock return and provide a credit for the stock returned.

This action was closed on the 25/09/2018.
Contact Information 1800 251 150 - Bausch + Lomb Customer Service