ACRYSOF IQ TORIC INTRAOCULAR LENS (IOL)
FDA premarket approval P930014/S029 · decided 2009-02-05
Approval details
- PMA number
- P930014
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACRYSOF IQ TORIC INTRAOCULAR LENS (IOL)
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2008-12-12
- Decision date
- 2009-02-05
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR IOL MODELS SN6AT3, SN6AT4 AND SN6AT5. THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ TORIC INTRAOCULAR LENSES AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR VISUAL CORRECTION OFAPHAKIA 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 INDEP
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510(k) clearances by this applicant
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|---|---|---|
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| Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (K242184) | Alcon Laboratories, Inc. | 2024-12-04 |
| UNITY VCS (8065000296); UNITY CS (8065000297) (K233876) | Alcon Laboratories, Inc. | 2024-06-21 |
| Centurion™ Vision System (Active Sentry™) (8065753057) (K233902) | Alcon Laboratories, Inc. | 2024-01-10 |
| Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856) | Alcon Laboratories, Inc. | 2023-12-29 |