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U.S. Department of Health and Human Services

Class 2 Device Recall Akreos Advance Optics Aspheric Lens

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  Class 2 Device Recall Akreos Advance Optics Aspheric Lens see related information
Date Initiated by Firm December 08, 2008
Date Posted September 09, 2009
Recall Status1 Terminated 3 on November 05, 2009
Recall Number Z-1911-2009
Recall Event ID 52652
PMA Number P060022 
Product Classification Akreos Advance Optics Aspheric Lens - Product Code HQL
Product Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL.
Code Information Lot Numbers: 1829803, 1829803, 1829814, 1829823 and 1829824.
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Lisa Graney
585-338-6612
Manufacturer Reason
for Recall		 Affected lenses were inadvertently shipped to Bausch & Lomb's European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for endotoxin limits.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action All consignees were notified via phone, telefax and letter. Products are to be returned to Bausch & Lomb's European Logistics Center (ELC) for destruction. Direct questions to Bausch and Lomb, Inc. by calling 1-585-338-6612.
Quantity in Commerce 158
Distribution Foreign Distribution only -- Algeria, Belgium, Bulgaria, Croatia, Germany, Hungary, Ireland, Israel, Italy, Mexico, Portugal, Spain, Thailand and United Kingdom.
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.
PMA Database PMAs with Product Code = HQL and Original Applicant = Bausch & Lomb, Inc.
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