PMA P190018S052

Device
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S052
Product code
HQL
Decision date
2026-07-02
Classification
Ophthalmic
Generic name
intraocular lens
Approval order statement
a change to the image quality and IOL power measurement equipment for Clareon and AcrySof multifocal IOLs

Current openFDA PMA Record#

Device
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S052
Product code
HQL
Generic name
intraocular lens
Decision date
2026-07-02
Decision code
OK30
Date received
2026-06-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a change to the image quality and IOL power measurement equipment for Clareon and AcrySof multifocal IOLs