AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P960028 · decided 1997-09-05
Approval details
- PMA number
- P960028
- Trade name
- AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 1996-09-03
- Decision date
- 1997-09-05
- Days to decision
- 367 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the Model SA4ON AMO(R) Array(R) Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens (IOL). This device is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed and who may benefit from useful near vision without reading add and increased spectacle independence across a range of distances where the potential visual effects associated with multifocality are acceptable. The lens is intende
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