Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Trifocal UV Absorbing IOL, Clareon PanOptix Trifocal Hydroph
FDA premarket approval P190018/S009 · decided 2021-03-15
Approval details
- PMA number
- P190018
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Trifocal UV Absorbing IOL, Clareon PanOptix Trifocal Hydroph
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2020-12-14
- Decision date
- 2021-03-15
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval to expand dioptric-power range to 6.0 D - 34.0 D for Clareon PanOptix Trifocal Hydrophobic IOL (CNWTT0), Clareon PanOptix Trifocal UV Absorbing IOL (CCWTT0), and Clareon PanOptix Trifocal Hydrophobic IOL models CNWTT3-CNWTT6, as well as approval for Clareon PanOptix Toric Trifocal Hydrophobic IOL with the AutonoMe Automated Preloaded Delivery Device (CNATT3-CNATT6).
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