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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 IQ ReSTOR Intraocular Lenses
Generic NameLens, multifocal intraocular
ApplicantAlcon Research, Ltd.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP040020
Supplement NumberS093
Date Received05/15/2020
Decision Date07/01/2021
Product Codes MFK HQL 
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  
Approval for change to the Analytical Testing Method for the determination of Residual Monomer in AcrySof® Intraocular Lenses.
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