FDA.reportPublic FDA data

PMA P190018S007

Device
Clareon Intraocular Lenses with the AutonoMe Delivery System
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S007
Product code
HQL
Decision date
2020-11-12
Generic name
intraocular lens
Approval order statement
Adding an alternate supplier for the hydrophilic monomer used for the manufacturing of the Clareon Intraocular Lens (IOL) in 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
S007
Product code
HQL
Generic name
intraocular lens
Decision date
2020-11-12
Decision code
OK30
Date received
2020-10-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding an alternate supplier for the hydrophilic monomer used for the manufacturing of the Clareon Intraocular Lens (IOL) in the Alcon Ireland manufacturing site.