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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 LENS
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP040020
Supplement NumberS060
Date Received02/04/2016
Decision Date02/29/2016
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 a new quality control measurement system for measuring spherical aberrations for the AcrySof® Multifocal IOL Model SN6AD1 at the Cork, Ireland manufacturing site and for the AcrySof® Multifocal IOL Models SN6AD1 & MN6AD1 at the Huntington, West Virginia manufacturing site.
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