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U.S. Department of Health and Human Services

Class 3 Device Recall Equate MutiPurpose Solution, For Soft Contact Lenses, Sterile

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  Class 3 Device Recall Equate MutiPurpose Solution, For Soft Contact Lenses, Sterile see related information
Date Initiated by Firm June 30, 2011
Date Posted August 19, 2011
Recall Status1 Terminated 3 on November 16, 2011
Recall Number Z-3042-2011
Recall Event ID 59525
510(K)Number K020802  
Product Classification Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
Product Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL), Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716

Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.
Code Information Lot number: GC1107
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Jennifer Murray
585-338-6000
Manufacturer Reason
for Recall		 Muti-purpose solution bottles, lot GC1107 were packaged in a carton that was marked with an incorrect lot code and expiration date.
FDA Determined
Cause 2		 Packaging
Action Bausch & Lomb Inc. notified the affected customer via teleconference and e-mail on June 30, 2011. The e-mail describes the product, problem, and actions to be taken by the customer. The customer was instructed to hold and stop shipments of any inventory of the affected product. An official recall was initiated with the customer on July 8, 2011 via e-mail and teleconference. Customer was asked to review their inventory and store returns, and send any of the affected product to Bausch & Lomb Returns Dept., 130 Commerce Drive, Greenville, SC 29615.
Quantity in Commerce 1200 bottles
Distribution Distribution-in the state of AK only
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 INCORPORATED
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