Clareon PanOptix Pro Trifocal IOLs
FDA premarket approval P190018/S030 · decided 2024-03-05
Approval details
- PMA number
- P190018
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Clareon PanOptix Pro Trifocal IOLs
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2023-12-06
- Decision date
- 2024-03-05
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the Clareon PanOptix Pro Trifocal IOLs in both the lens case and AutonoMe Automated Pre-loaded Delivery System configurations.
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