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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 Recall
AcrySof ReSTOR Intraocular Lens
see related information
Date Posted February 15, 2007
Recall Status1 Terminated on April 09, 2008
Recall Number Z-0429-2007
Recall Event ID 37009
Premarket Approval
PMA Numbers
P040020 P930014
Product Classification Lens, Multifocal Intraocular - 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/
Manufacturer
Alcon Laboratories, Inc
6201 South Fwy
Fort Worth, Texas 76134-2001
Manufacturer Reason
for Recall
Intraocular lenses exposed to extreme temperatures while in storage.
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 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 Applicant = ALCON LABORATORIES, INC.
PMAs with Product Code = MFK and Applicant = ALCON RESEARCH, LTD.
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