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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb Boston Conditioning Solution, Original Formula

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 Class 2 Device Recall Bausch & Lomb Boston Conditioning Solution, Original Formulasee related information
Date Initiated by FirmOctober 30, 2009
Date PostedDecember 22, 2009
Recall Status1 Terminated 3 on August 29, 2012
Recall NumberZ-0553-2010
Recall Event ID 53873
510(K)NumberK983836 
Product Classification Accessories solution ultrasonic cleaners for lenses / products contact lens care rigid gas permeable - Product Code MRC
ProductBausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles.
Code Information All lots
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information ContactDouglas J. Fortunato
585-338-6000
Manufacturer Reason
for Recall		The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors.
FDA Determined
Cause 2		Other
ActionConsignees were notified by mail on/about 11/06/2009. All consignees were asked to review their inventory, and return any of the affected products to Stericycle Pharmaceutical Services. A Business Reply Card was included to be returned via US mail within 5 days. A packing slip was provided to be affixed to a pre-paid USP shipping label for return.
Quantity in Commerce159,672 bottles
DistributionU.S. Nationwide, Canada and Hong Kong
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.
510(K) Database510(K)s with Product Code = MRC
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