| 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. |
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| Device | ACRYSOF TORIC IOL & ACRYSOF IQ TORIC IOL |
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| Generic Name | intraocular lens |
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| Regulation Number | 886.3600 |
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| Applicant | ALCON LABORATORIES, INC.
6201 SOUTH FREEWAY DR.
FORT WORTH, TX 76134 |
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| PMA Number | P930014 |
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| Supplement Number | S045 |
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| Date Received | 08/31/2010 |
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| Decision Date | 05/03/2011 |
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| Product Code |
HQL |
| Docket Number | 11M-0338 |
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| Notice Date | 05/12/2011 |
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| Advisory Committee |
Ophthalmic |
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| Clinical Trials | NCT00967473
|
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| Supplement Type | Panel Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Post-Approval Study | Show Report Schedule and Study Progress |
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