Intraocular Lens
Basic Information
- Device Name
- Intraocular Lens
- Trade Name
- Clareon PanOptix Pro Trifocal Intraocular Lens (IOL), Clareon PanOptix Pro Trifocal Toric IOLs, Clareon PanOptix Pro Tr
- PMA Number
- P190018
- Supplement Number
- S029
- Device Class
- FDA Class 3
- Product Code
- HQL
- Generic Name
- intraocular lens
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 18, 2023
- Date Received
- September 27, 2023
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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 PXYAT0, Clareon PanOptix Pro Trifocal Toric IOLs with the AutonoMe Automated Pre-loaded Delivery System Models PXYAT3 PXYAT6, Clareon PanOptix Pro Trifocal UV Absorbing IOL with the AutonoMe Automated Pre-loaded Delivery System Model PXCAT0, Clareon PanOptix Pro Trifocal Toric UV Absorbing IOLs with the AutonoMe Automated Pre-loaded Delivery System Models PXCAT3 PXCAT6
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQL | Intraocular Lens | FDA class 3 | Ophthalmic |