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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 RESTOR IQ IOL
Classification Namelens, multifocal intraocular
Generic Name21 cfr 886.3600 intraocular lens(iol)
Regulation Number886.3600
ApplicantALCON RESEARCH, LTD.
PMA NumberP040020
Supplement NumberS010
Date Received04/15/2008
Decision Date06/20/2008
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the trade name of the device from acrysof restor aspheric apodized diffractive posterior chamber intraocular lens (iol) to acrysof iq restor apodized diffractive posterior chamber iol. The device will be marketed under the trade name acrysof iq restor apodized diffractive posterior chamber iol, model sn6ad3, and is indicated for primary implantation in the capsular bag 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.
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