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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 IOLS +3.0 D
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP040020
Supplement NumberS012
Date Received07/01/2008
Decision Date12/22/2008
Product Code MFK 
Advisory Committee Ophthalmic
Clinical TrialsNCT00684138
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ACRYSOF IQ RESTOR INTRAOCULAR LENS +3.0 ADD POWER.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ RESTORINTRAOCULAR LENS +3.0D (MODELS SN6AD1 AND MN6AD1) AND IS INDICATED FOR PRIMARYIMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS INADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THIS LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
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