SILICONE POSTERIOD CHAMBER INTRAOCULAR LENS, MODEL Z9000 INTRAOCULAR LENS MD 911A
FDA premarket approval P990080/S001 · decided 2001-10-16
Approval details
- PMA number
- P990080
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SILICONE POSTERIOD CHAMBER INTRAOCULAR LENS, MODEL Z9000 INTRAOCULAR LENS MD 911A
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2001-09-05
- Decision date
- 2001-10-16
- Days to decision
- 41 days
- Decision code
- APPR
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A NEW FOLDABLE, ULTRAVIOLET LIGHT-ABSORBING, POSTERIOR CHAMBER INTRAOCULAR LENS MODEL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL Z9000 AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
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