PMA P040020S119

Device
AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S119
Product code
MFK
Decision date
2026-07-02
Classification
Ophthalmic
Generic name
Lens, multifocal intraocular
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
AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S119
Product code
MFK
Generic name
Lens, multifocal intraocular
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