ACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5
FDA premarket approval P930014/S016 · decided 2005-12-16
Approval details
- PMA number
- P930014
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2005-11-14
- Decision date
- 2005-12-16
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR IOL MODELS SN60T3, SN60T4 AND SN60T5. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF TORIC SINGLE-PIECE NATURAL IOL AND 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 SPECTACLE INDEPENDENCE FOR DISTANCE VISION.
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510(k) clearances by this applicant
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