Date Initiated by Firm |
October 30, 2009 |
Date Posted |
December 22, 2009 |
Recall Status1 |
Terminated 3 on August 29, 2012 |
Recall Number |
Z-0553-2010 |
Recall Event ID |
53873 |
510(K)Number |
K983836
|
Product Classification |
Accessories solution ultrasonic cleaners for lenses / products contact lens care rigid gas permeable - Product Code MRC
|
Product |
Bausch & 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 Contact |
Douglas 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 |
Action |
Consignees 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 Commerce |
159,672 bottles |
Distribution |
U.S. Nationwide, Canada and Hong Kong |
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 = MRC and Original Applicant = POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
|