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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 NumberS012
Date Received07/01/2008
Decision Date12/22/2008
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Clinical Trials NCT00684138
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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 restor intraocular lens +3. 0d (models sn6ad1 and mn6ad1) and is indicated for primary implantation 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. This lens is intended to be placed in the capsular bag.