TECNIS CL FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL Z9002)
FDA premarket approval P880081/S032 · decided 2006-07-20
Approval details
- PMA number
- P880081
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS CL FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL Z9002)
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2006-05-30
- Decision date
- 2006-07-20
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A CHANGE IN HAPTIC MATERIAL, ADDITION OF THE OPTIEDGE AND OF A MODIFIED PROLATE ANTERIOR OPTIC SURFACE TO THE SI20NB LENS AND LABELING CLAIMS FOR REDUCED POSTOPERATIVE SPHERICAL ABERRATIONS AND IMPROVED NIGHT-DRIVING SIMULATOR PERFORMANCE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECNIS CL FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL Z9002) AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A
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