Clareon PanOptix Pro Trifocal Intraocular Lens (IOL), Clareon PanOptix Pro Trifocal Toric IOLs, Clareon PanOptix Pro Tr
FDA premarket approval P190018/S029 · decided 2023-12-18
Approval details
- PMA number
- P190018
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Clareon PanOptix Pro Trifocal Intraocular Lens (IOL), Clareon PanOptix Pro Trifocal Toric IOLs, Clareon PanOptix Pro Tr
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2023-09-27
- Decision date
- 2023-12-18
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- approval for the following Clareon PanOptix Pro models as a minor optical modification of the approved Clareon PanOptix models: Clareon PanOptix Pro Trifocal Intraocular Lens (IOL) Model PXYWT0, Clareon PanOptix Pro Trifocal Toric IOLs Models PXYWT3 PXYWT6, Clareon PanOptix Pro Trifocal UV Absorbing IOL Model PXCWT0, Clareon PanOptix Pro Trifocal Toric UV Absorbing IOLs Models PXCWT3 PXCWT6 , Clareon PanOptix Pro Trifocal IOL with the AutonoMe Automated Pre-loaded Delivery System Model PXYAT
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