ACRYSOF SINGLE-PIECE POSTERIOR CHAMBER IOL
FDA premarket approval P930014/S014 · decided 2004-04-29
Approval details
- PMA number
- P930014
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACRYSOF SINGLE-PIECE POSTERIOR CHAMBER IOL
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2004-04-16
- Decision date
- 2004-04-29
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL TO MODIFY THE INDICATIONS STATEMENT, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS FOLLOWING CATARACT SURGERY. PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION ARE PERFORMED OR WHERE A CATARACTOUS LENS HAS BEEN REMOVED. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULTS FOLLOWING CATARACT SURGERY.
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