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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 Multifocal Intraocular Lenses
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP040020
Supplement NumberS098
Date Received03/26/2021
Decision Date04/22/2021
Product Code MFK 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Add an alternate supplier for a raw material (i.e. initiator) used in the manufacturing process.
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