PMA P040020S118

Device
AcrySof® IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S118
Product code
MFK
Decision date
2026-03-02
Classification
Ophthalmic
Generic name
Lens, multifocal intraocular
Approval order statement
addition of a new purified water system at the Alcon Huntington North Manufacturing Site

Current openFDA PMA Record#

Device
AcrySof® IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S118
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2026-03-02
Decision code
OK30
Date received
2026-02-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
addition of a new purified water system at the Alcon Huntington North Manufacturing Site