TECNIS CL Foldable Silicone Intraocular Lens
FDA premarket approval P880081/S043 · decided 2019-06-27
Approval details
- PMA number
- P880081
- Supplement
- S043
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TECNIS CL Foldable Silicone Intraocular Lens
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2019-05-28
- Decision date
- 2019-06-27
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval to revise the TECNIS® CL, Model Z9002, Directions for Use (DFU) to inform the user of the interaction of silicone material with inherent risk factors as follows: Addition of the following to Warning #10: It has been reported that silicone oil droplets, which remain adherent to the intraocular lens, may reduce the optical quality of the lens and obscure the view of the fundus
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