FDA.reportPublic FDA data

PMA P040020S101

Device
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S101
Product code
MFK
Decision date
2021-10-01
Generic name
Lens, multifocal intraocular
Approval order statement
Replacement of obsolete components and a minor software upgrade for the optical inspection equipment used to measure AcrySof PanOptix and PanOptix Toric intraocular lenses.

Current openFDA PMA Record#

Device
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S101
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2021-10-01
Decision code
OK30
Date received
2021-09-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of obsolete components and a minor software upgrade for the optical inspection equipment used to measure AcrySof PanOptix and PanOptix Toric intraocular lenses.