FDA.reportPublic FDA data

PMA P040020S078

Device
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S078
Product code
MFK
Decision date
2018-04-11
Classification
Lens, Multifocal Intraocular
Generic name
Lens, multifocal intraocular
Approval order statement
Implementation of an automated dimensional inspection system as an alternate process for dimensional inspection of AcrySof Intraocular Lenses at the Alcon Ireland manufacturing site.

Current openFDA PMA Record#

Device
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S078
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2018-04-11
Decision code
OK30
Date received
2018-03-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of an automated dimensional inspection system as an alternate process for dimensional inspection of AcrySof Intraocular Lenses at the Alcon Ireland manufacturing site.