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PMA P040020S086

Device
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S086
Product code
MFK
Decision date
2018-12-14
Classification
Lens, Multifocal Intraocular
Generic name
Lens, multifocal intraocular
Approval order statement
Reducing the frequency of monomer inhibitor removal in-process testing for the AcrySof Posterior Chamber Single Piece Intraocular Lens and the AcrySof ReSTOR Posterior Chamber Intraocular Lens manufactured at the Cork Ireland site.

Current openFDA PMA Record#

Device
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S086
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2018-12-14
Decision code
OK30
Date received
2018-11-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Reducing the frequency of monomer inhibitor removal in-process testing for the AcrySof Posterior Chamber Single Piece Intraocular Lens and the AcrySof ReSTOR Posterior Chamber Intraocular Lens manufactured at the Cork Ireland site.