ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRELOADED DELIVERY SYSTEM
FDA premarket approval P930014/S084 · decided 2015-09-29
Approval details
- PMA number
- P930014
- Supplement
- S084
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRELOADED DELIVERY SYSTEM
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2015-08-07
- Decision date
- 2015-09-29
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL TO MODIFY THE ACRYSERT C DELIVERY SYSTEM BY REDUCING THE SIZE OF THE NOZZLE TIP, ADDING AN EXTERNAL NOZZLE TIP DEPTH GUARD, AND ADDING A PLUNGER SPRING AND PLUNGER LOCK, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ ASPHERIC INTRAOCULAR LENS WITH ULTRASERT PRELOADED DELIVERY SYSTEM. THE ACRYSOF IQ POSTERIOR CHAMBER INTRAOCULAR LENSES ARE INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS FOLLOWING CATARAC
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510(k) clearances by this applicant
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