- Device
- Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Trifocal UV Absorbing IOL, Clareon PanOptix Trifocal Hydroph
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S009
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2021-03-15
- Decision code
- APPR
- Date received
- 2020-12-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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).