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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceACRYSOF IQ RESTOR +2.5 D MULTIFOCAL INTRAOCULAR LENS
Classification Namelens, multifocal intraocular
Generic Namelens, multifocal intraocular
Regulation Number886.3600
Applicant
Alcon Research, Ltd.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP040020
Supplement NumberS050
Date Received08/30/2013
Decision Date04/13/2015
Product Code
MFK[ Registered Establishments with MFK ]
Docket Number 15M-1325
Notice Date 04/29/2015
Advisory Committee Ophthalmic
Clinical Trials NCT01510717
Supplement Typepanel track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the acrysof® iq restor® +2. 5 d multifocal intraocular lens (iol), model sv25t0. This device is indicated for primary implantation in the capsular bag of the eye 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 spectacleindependence.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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