Clareon PanOptix Trifocal Hydrophobic IOL, and Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Pre
FDA premarket approval P190018/S002 · decided 2020-07-20
Approval details
- PMA number
- P190018
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Clareon PanOptix Trifocal Hydrophobic IOL, and Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Pre
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2020-04-21
- Decision date
- 2020-07-20
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the Clareon PanOptix Trifocal Hydrophobic IOL Model CNWTT0 and the Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Preloaded Delivery System Model CNATT0.
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