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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.
Classification Namelens, multifocal intraocular
Generic Name21 cfr 886.3600 intraocular lens(iol)
Regulation Number886.3600
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 spectacle independence.
Approval Order Approval Order