ACRYSOF IQ RESTOR IOLS +3.0 D
FDA premarket approval P040020/S012 · decided 2008-12-22
Approval details
- PMA number
- P040020
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACRYSOF IQ RESTOR IOLS +3.0 D
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2008-07-01
- Decision date
- 2008-12-22
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE ACRYSOF IQ RESTOR INTRAOCULAR LENS +3.0 ADD POWER.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ RESTORINTRAOCULAR LENS +3.0D (MODELS SN6AD1 AND MN6AD1) AND IS INDICATED FOR PRIMARYIMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS INADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THIS LENS IS INTENDED TO BE PLACED IN THE CAPS
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