Date Initiated by Firm | March 03, 2017 |
Create Date | March 05, 2018 |
Recall Status1 |
Terminated 3 on June 25, 2018 |
Recall Number | Z-0858-2018 |
Recall Event ID |
76874 |
Product Classification |
Knife, ophthalmic - Product Code HNN
|
Product | LASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519, 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. |
Code Information |
none |
Recalling Firm/ Manufacturer |
Bausch & Lomb Inc Irb 1400 Goodman St N Rochester NY 14609-3547
|
For Additional Information Contact | 800-338-2020 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 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. |
Quantity in Commerce | 1,236,749 knives in total |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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