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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAcrySof Posterior Chamber Single Piece Intraocular Lenses
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALCON LABORATORIES, INC.
6201 SOUTH FREEWAY DR.
FORT WORTH, TX 76134
PMA NumberP930014
Supplement NumberS118
Date Received11/20/2018
Decision Date12/14/2018
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Reducing the frequency of monomer inhibitor removal in-process testing for the AcrySof Posterior Chamber Single Piece Intraocular Lens and the AcrySof ReSTOR Posterior Chamber Intraocular Lens manufactured at the Cork Ireland site.
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