PMA P040020S121

Device
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S121
Product code
MFK
Decision date
2026-07-02
Classification
Ophthalmic
Generic name
Lens, multifocal intraocular
Approval order statement
approval of ECH residual test method change at Alcon Research, LLC, WV USA

Current openFDA PMA Record#

Device
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S121
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2026-07-02
Decision code
OK30
Date received
2026-06-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval of ECH residual test method change at Alcon Research, LLC, WV USA