TECNIS CL FOLDABLE SILICONE INTRAOCULAR LENS
FDA premarket approval P880081/S040 · decided 2016-07-29
Approval details
- PMA number
- P880081
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS CL FOLDABLE SILICONE INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2016-06-02
- Decision date
- 2016-07-29
- Days to decision
- 57 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Change in the Bioburden Test Method used in the manufacturing of the TECNIS CL, Model Z9002, SENSAR Acrylic Intraocular Lenses (IOLs), Models AR40, AAB00, ZCB00, ZCB00V, and ZMB00, and TECNIS Acrylic Monofocal IOL, Model ZA9003.
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