TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00
FDA premarket approval P980040/S023 · decided 2008-05-27
Approval details
- PMA number
- P980040
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2008-03-21
- Decision date
- 2008-05-27
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR REVISIONS TO THE LABELING FOR THE TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00 AS FOLLOWS: 1) MODIFICATIONS TO THE DEVICE DESCRIPTION SECTION TO INCLUDE AN ADDITIONAL DESCRIPTION OF WAVEFRONT-DESIGNED ASPHERIC OPTIC, SQUARED POSTERIOR OPTIC EDGE, FROSTED OPTIC EDGE, AN OPTICAL IMAGE QUALITY GRAPH FOR THE ASPHERIC OPTIC; 2) MODIFICATIONS TO THE ADVERSE EVENTS SAND THE CLINICAL TRIAL SECTIONS TO REFLECT DATA FROM THE ONE-YEAR CLINICAL STUDY RESULTS; AND 3) OTHER ADMINISTRATIVE CHANG
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