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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb

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  Class 2 Device Recall Bausch & Lomb see related information
Date Initiated by Firm February 27, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on May 03, 2012
Recall Number Z-1093-04
Recall Event ID 29055
Product Classification Intraocular Lens - Product Code HQL
Product SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.
Code Information 8XRJ
Recalling Firm/
Bausch & Lomb Surgical, Inc.
21 N Park Place Blvd
Clearwater FL 33759-3917
For Additional Information Contact Mary Adams
Manufacturer Reason
for Recall
Lens may be labeled with incorrect diopter size.
FDA Determined
Cause 2
Action The firm telephoned direct medical facility consginees on 2/27/2004 instructing to determine the disposition of the lenses and to return unimplanted ones. Follow-up phone calls were made in March 2004 for unresolved consignees.
Quantity in Commerce 36
Distribution Nationwide & puerto rico. FL, MA, CA, CT, MI, NY, IN, ID, GA, PA, IL, CO, TN, NC, PR, TX, ME and OH.
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.