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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 Apodized Diffractive Optic Posterior Chamber IOL
Generic NameLens, multifocal intraocular
ApplicantAlcon Research, Ltd.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP040020
Supplement NumberS108
Date Received01/31/2024
Decision Date07/12/2024
Product Codes MFK MJP 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
reduction from 100% to sampling plan for dimensional inspection of all Clareon and AcrySof Single-Piece toric lenses
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