PMA P040020S102

Device
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S102
Product code
MFK
Decision date
2022-03-25
Generic name
Lens, multifocal intraocular
Approval order statement
Modification to the testing frequency of the acrylate monomer inhibitor removal in-process test.

Current openFDA PMA Record#

Device
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S102
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2022-03-25
Decision code
OK30
Date received
2022-03-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to the testing frequency of the acrylate monomer inhibitor removal in-process test.