LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, 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.
FDA Recall Z-0889-2018 · Posted None
Recalling FirmBausch & Lomb Inc Irb
Recall StatusTerminated
Product CodeHNN
Date Initiated2017-03-03
Date Terminated2018-06-25
Product Quantity1,236,749 knives in total
Reason for Recall
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.
Firm 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 calling 1-800-338-2020, Customer Service (option 2), Product Returns and Adverse Event Reporting (option 2).
Please contact the Bausch + Lomb Surgical Customer Service team with any questions or concerns regarding this process: 1-800-338-2020.
Root Cause
Process design
Distribution Pattern
US Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.