FDA.reportPublic FDA data

PMA P190018S008

Device
Clareon Intraocular Lenses with the AutonoMe Delivery System
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S008
Product code
HQL
Decision date
2020-11-24
Generic name
intraocular lens
Approval order statement
Implementation of new optical metrology equipment, Gen-3 MTF System, to be used as part of the manufacturing process for Clareon PanOptix Intraocular Lenses at the Alcon Ireland manufacturing site.

Current openFDA PMA Record#

Device
Clareon Intraocular Lenses with the AutonoMe Delivery System
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S008
Product code
HQL
Generic name
intraocular lens
Decision date
2020-11-24
Decision code
OK30
Date received
2020-10-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of new optical metrology equipment, Gen-3 MTF System, to be used as part of the manufacturing process for Clareon PanOptix Intraocular Lenses at the Alcon Ireland manufacturing site.