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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls

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 Class 2 Recall
AcrySof® ReSTOR® Intraocular Lens
see related information
Date Posted February 15, 2007
Recall Number Z-0429-2007
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
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.
 
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