Date Initiated by Firm | December 14, 2006 |
Date Posted | February 15, 2007 |
Recall Status1 |
Terminated 3 on April 09, 2008 |
Recall Number | Z-0431-2007 |
Recall Event ID |
37009 |
PMA Number | P930014 |
Product Classification |
Intraocular Lens - Product Code MFK
|
Product | AcrySof Intraocular Lens |
Code Information |
Model MA60AC, serial number 989984.028 |
Recalling Firm/ Manufacturer |
Alcon Laboratories, Inc 6201 South Fwy Fort Worth TX 76134-2001
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Manufacturer Reason for Recall | Intraocular lenses exposed to extreme temperatures while in storage. |
FDA Determined Cause 2 | Other |
Action | The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006. |
Quantity in Commerce | one unit |
Distribution | Nationwide. |
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.
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