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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
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP040020
Supplement NumberS083
Date Received09/12/2018
Decision Date10/11/2018
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  
Modifications to the control and monitoring program of the Environmental Controlled Areas for the AcrySof® IQ ReSTOR® Intraocular Lenses (Model Number, SN6AD1) and the AcrySof® Single Piece Intraocular Lenses (Models SN60AT, SA60AT, SN60WF, SA60WF, SN6AT3-T9) at the Alcon Cork, Ireland manufacturing facility.
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