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U.S. Department of Health and Human Services

Class 2 Device Recall Laseredge Knife

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 Class 2 Device Recall Laseredge Knifesee related information
Date Initiated by FirmJuly 11, 2016
Create DateAugust 24, 2019
Recall Status1 Terminated 3 on August 30, 2019
Recall NumberZ-2366-2019
Recall Event ID 74671
Product Classification Knife, ophthalmic - Product Code HNN
ProductLaseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
Code Information Lot Number: MAXZ170  Expiry Date: 01/28/2021 
FEI Number 1317628
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc Irb
1400 N Goodman St
Rochester NY 14609-3547
For Additional Information Contact
800-338-2020
Manufacturer Reason
for Recall		Possible dull knife edge
FDA Determined
Cause 2		Vendor change control
ActionOn July 14, 2016, Baush + Lomb issued Medical Device Voluntary Product Recall notices to customers. Customers were instructed to take the following actions: 1. Please review your inventory and hold all unused boxes 2. Quarantine any unused boxes (full and partial) and take the following steps to return the product to Bausch + Lomb at the recalling firm's expense. 3. Please complete the 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).
Quantity in Commerce165 packs/6 blades (990 individiual blades)
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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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