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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.
 
Trade NameACRYSOF IQ RESTOR IOLS 3.0 AND 4.0 D ADD POWERS
Classification Namelens, multifocal intraocular
Generic Name21 cfr 886.3600 intraocular lens(iol)
Regulation Number886.3600
ApplicantALCON RESEARCH, LTD.
PMA NumberP040020
Supplement NumberS014
Date Received03/09/2009
Decision Date08/20/2009
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Clinical Trials NCT00684138
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the labeling, revising the directions for use (dfu) and patient brochure with updated six-month follow up data from the clinical investigation for the lenses. The devices, as modified will be marketed under the trade name acrysof iq restor intraocular lenses (iols) +3. 0 d (models: sn6ad1 and mn6ad1) and +4. 0 d (models: sn6ad3 and mn6ad3) add powers and is indicated for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.
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