Recall Z-0893-2018 ยท HNN Knife, Ophthalmic
Bausch & Lomb Inc Irb
LASEREDGE Knives, 1.8mm x 2.2mm TRAPEZOID ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7603G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
| Date | Mar 3, 2017 |
| Status | Terminated |
| Reason | The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing. |
| Root cause | Process design |
| Action | On March 3, 2017 Bausch + Lomb , distributed Urgent Medical Device Recall notices and Acknowledgement Forms to customers via FedEx. Customers were advised to: 1. Please review your inventory and quarantine all unused (full and partial) boxes of LaserEdge" knives (6/Box or individual packaged knives) affected lots. 2. Complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact Bausch + Lomb to obtain a Return Material Authorization Number (RMA) and arrange for a pickup of the identified product. You can contact the Bausch + Lomb Surgical Customer Service team by |
| Quantity | 1,236,749 knives in total |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.