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/ Manufacturer |
Allergan Medical Optics Inc 1700 E Saint Andrew Pl Santa Ana CA 92705-4933
|
For Additional Information Contact |
Sandra Selvaggie 714-247-8656
|
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 |
Other |
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
|
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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
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