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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 APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP040020
Supplement NumberS005
Date Received08/06/2007
Decision Date10/24/2007
Product Code MFK 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR EXPANSION OF THE DIOPTRIC RANGE OF THE REFERENCED MODELS FROM 10.0D TO 30.0D TO 6.0D TO 30.0D. THE DEVICE MODELS, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODELS SA60D3, SN60D3, MA60D3 AND MN60D3, AND ARE INDICATED 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. THESE LENSES ARE INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
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