PMA P190018S002

Device
Clareon PanOptix Trifocal Hydrophobic IOL, and Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Pre
Applicant
Alcon Laboratories, LLC
Product code
MFK
Decision date
2020-07-20
Generic name
Lens, multifocal intraocular
Approval order 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.

Current openFDA PMA Record#

Device
Clareon PanOptix Trifocal Hydrophobic IOL, and Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Pre
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S002
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2020-07-20
Decision code
APPR
Date received
2020-04-21
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order 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.