Date Initiated by Firm |
July 11, 2016 |
Create Date |
August 24, 2019 |
Recall Status1 |
Terminated 3 on August 30, 2019 |
Recall Number |
Z-2366-2019 |
Recall Event ID |
74671 |
Product Classification |
Knife, ophthalmic - Product Code HNN
|
Product |
Laseredge 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 |
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 |
Action |
On 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 Commerce |
165 packs/6 blades (990 individiual blades) |
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.
|