TECNIS CL Foldable Silicone Intraocular Lens
FDA premarket approval P880081/S042 · decided 2019-04-05
Approval details
- PMA number
- P880081
- Supplement
- S042
- 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
- 2019-03-08
- Decision date
- 2019-04-05
- Days to decision
- 28 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 (such as asteroid hyalosis) as follows:1) Addition of diabetic retinopathy as an example in Warning #10 to state: The use of silicone lenses in patients with current vitreoretinal disease or those who are at high risk for future vitreoretinal disease (i.e. diabetic retinopathy, etc.) that may require silicone oil as part of therapy should
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