TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL)
FDA premarket approval P980040/S049 · decided 2014-12-17
Approval details
- PMA number
- P980040
- Supplement
- S049
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL)
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2014-06-30
- Decision date
- 2014-12-17
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE TECNIS® MULTIFOCAL 1-PIECE INTRAOCULAR LENS, MODELS ZKB00 AND ZLB00. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH ANDWITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THEINTRAOCULAR LENSES ARE INTENDED TO BE PLACED IN THE CAPSULAR BAG.
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