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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 TORIC IOL & ACRYSOF IQ TORIC IOL
Classification Nameintraocular lens
Generic Nameintraocular lenses (iol)21 cfr 886.3600/class iii
Regulation Number886.3600
ApplicantALCON RESEARCH, LTD.
PMA NumberP930014
Supplement NumberS045
Date Received08/31/2010
Decision Date05/03/2011
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 11M-0338
Notice Date 05/12/2011
Advisory Committee Ophthalmic
Clinical Trials NCT00967473
Supplement Typepanel track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the acrysof toric posterior chamber intraocular lens models sn60t6, sn60t7, sn60t8, and sn60t9 and acrysof iq toric posterior chamber intraocular lens models sn6at6, sn6at7, sn6at8 and sn6at9. This device is indicated for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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