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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 +3.0 D MULTIFOCAL TORIC 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 NumberS049
Date Received08/09/2013
Decision Date12/22/2016
Product Code
MFK[ Registered Establishments with MFK ]
Docket Number 16M-4657
Notice Date 03/07/2017
Advisory Committee Ophthalmic
Clinical Trials NCT01200511
NCT01257217
NCT01290068
NCT01323777
NCT01424189
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the AcrySof IQ ReSTOR +3.0 D Multifocal Toric Intraocular Lens. This device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia and pre-existing astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual refractive cylinder and increased spectacle independence. The lens is intended to be placed in the capsular bag.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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