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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 ReSTOR IOLs
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP040020
Supplement NumberS080
Date Received07/19/2018
Decision Date08/16/2018
Product Code MFK 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change to the IOL optic mold material for AcrySof® ReSTOR® Intraocular Lens Models SN6AD1, MN6AD1, SV25T0, SND1T3-T6, SV25T3-T6, SA6AD1, SA25T0, SAD1T3-T6, and SA25T3-T6.
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