TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
FDA premarket approval P080010 · decided 2009-01-16
Approval details
- PMA number
- P080010
- Trade name
- TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2008-04-02
- Decision date
- 2009-01-16
- Days to decision
- 289 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), MODELS ZM900 AND ZMA00.THE DEVICES ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE.
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