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U.S. Department of Health and Human Services

Class 2 Device Recall LaserEdge Knives

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  Class 2 Device Recall LaserEdge Knives see related information
Date Initiated by Firm March 03, 2017
Create Date March 05, 2018
Recall Status1 Terminated 3 on June 25, 2018
Recall Number Z-0870-2018
Recall Event ID 76874
Product Classification Knife, ophthalmic - Product Code HNN
Product LASEREDGE Knives, 2.6 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7550ADB, 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

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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