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U.S. Department of Health and Human Services

Class 2 Device Recall AMO Prestige Pack

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  Class 2 Device Recall AMO Prestige Pack see related information
Date Initiated by Firm March 29, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 04, 2004
Recall Number Z-0907-04
Recall Event ID 28904
510(K)Number K924235  
Product Classification Unit, Phacofragmentation - Product Code HQC
Product Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40
Code Information Lot # Exp. date 3JR190 10/2006 3KR128 11/2006 3LR100 12/2006 3MR002 12/2006 3MR047 12/2006 3MR048 12/2006 3MR081 01/2007 3MR082 01/2007 4AR045 01/2007 4AR050 01/2007 4AR058 01/2007 
Recalling Firm/
Allergan Medical Optics Inc
1700 E Saint Andrew Pl
Santa Ana CA 92705-4933
For Additional Information Contact Sandra Selvaggie
Manufacturer Reason
for Recall
The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile and may pose a potential risk of infection to the patient if used in a sterile field.
FDA Determined
Cause 2
Action On March 31, 2004, a product notification letter was mailed to all customers via certified mail. The customers were instructed to stop using, quarantine and return all units. They were instructed to complete the Facsimile form provided and faxed it to the AMO Customer Service at 888-324-0021. They were also instructed to call AMO Customer Service at 800-366-6554 to make arrangement to return the product.
Quantity in Commerce 19, 087
Distribution Distribution was to 67 domestic customers and internationally.
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 = HQC and Original Applicant = ALLERGAN MEDICAL OPTICS