| 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 |
|
| 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 |