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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 IQ IOL
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP040020
Supplement NumberS010
Date Received04/15/2008
Decision Date06/20/2008
Product Code MFK 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGING THE TRADE NAME OF THE DEVICE FROM ACRYSOF RESTOR ASPHERIC APODIZED DIFFRACTIVE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) TO ACRYSOF IQ RESTOR APODIZED DIFFRACTIVE POSTERIOR CHAMBER IOL. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ RESTOR APODIZED DIFFRACTIVE POSTERIOR CHAMBER IOL, MODEL SN6AD3, AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE.
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