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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb, Biotrue

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  Class 2 Device Recall Bausch & Lomb, Biotrue see related information
Date Initiated by Firm April 21, 2014
Date Posted May 06, 2014
Recall Status1 Terminated 3 on January 09, 2015
Recall Number Z-1554-2014
Recall Event ID 68095
510(K)Number K083757  
Product Classification contact lens solution - Product Code LYL
Product Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
Code Information Lot GK2127 (twin packs), SKU: 623588, GK2131 (twin packs), SKU: 623500, STL2019, (6 pk shelf display containing GK2131, SKU: 629743 and STL2025 (6 pk shelf display containing GK2127), SKU: 629743.
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc- Greenville Solutions Plant
8507 Pelham Rd
Greenville SC 29615-5749
For Additional Information Contact Robert H. Koger
864-281-2505
Manufacturer Reason
for Recall		 Out of specification results for one of the two disinfectants.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified via registered mail starting 04/21/2014.
Quantity in Commerce 256,440 bottles
Distribution US Nationwide.
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.
510(K) Database 510(K)s with Product Code = LYL and Original Applicant = BAUSCH & LOMB, INC.
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