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U.S. Department of Health and Human Services

Class 2 Device Recall AcrySof ReSTOR Intraocular Lens

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  Class 2 Device Recall AcrySof ReSTOR Intraocular Lens see related information
Date Initiated by Firm December 14, 2006
Date Posted February 15, 2007
Recall Status1 Terminated 3 on April 09, 2008
Recall Number Z-0429-2007
Recall Event ID 37009
PMA Number P040020 
Product Classification Intraocular Lens - Product Code MFK
Product AcrySof¿ ReSTOR¿ Intraocular Lens
Code Information Model SN60D3, Serial numbers: 968290.039; 934317.012; 934317.013; and 948332.080.
Recalling Firm/
Alcon Laboratories, Inc
6201 South Fwy
Fort Worth TX 76134-2001
Manufacturer Reason
for Recall
Intraocular lenses exposed to extreme temperatures while in storage.
FDA Determined
Cause 2
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 4 units
Distribution Nationwide.
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 = MFK and Original Applicant = Alcon Research, Ltd.