| 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 POSTERIOR CHANBER IOL, ACRYSOF TORIC SINGLE-PIECE NATURAL IOL, ACRYSOF IQ TORIC IOL & ACRYSOF 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 S. Fwy. Dr.
Fort Worth, TX 76134 |
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| PMA Number | P930014 |
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| Supplement Number | S085 |
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| Date Received | 09/08/2015 |
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| Decision Date | 12/04/2015 |
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| Product Code |
HQL |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | Real-Time Process |
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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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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR THE ALCON ONLINE TORIC IOL CALCULATOR WHICH IS A MODIFICATION OF THE TORIC IOL CALCULATORS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALCON ONLINE TORIC IOL CALCULATOR FOR THE ACRYSOF® TORIC AND IQ TORIC IOLS. THE ACRYSOF® TORIC AND IQ TORIC POSTERIOR CHAMBER INTRAOCULAR LENSES ARE INTENDED 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. |
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