ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES
FDA premarket approval P930014 · decided 1994-12-22
Approval details
- PMA number
- P930014
- Trade name
- ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1993-05-28
- Decision date
- 1994-12-22
- Days to decision
- 573 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the ACRYSOf® Models MA60BM and MA30BA Ultraviolet-Absorbing Acrylic Foldable UV-Absorbing Posterior Chamber Intraocular Lenses (IOLs). These devices are indicated for replacement of the human lens to achieve visual correction of aphakia in patients 60 years of age and older when extracapsular cataract extraction or phacoemulsification are performed. These lenses are intended for placement in the capsular bag.
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