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PMA P040020S083

Device
AcrySof IQ ReSTOR Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S083
Product code
MFK
Decision date
2018-10-11
Classification
Lens, Multifocal Intraocular
Generic name
Lens, multifocal intraocular
Approval order statement
Modifications to the control and monitoring program of the Environmental Controlled Areas for the AcrySof® IQ ReSTOR® Intraocular Lenses (Model Number, SN6AD1) and the AcrySof® Single Piece Intraocular Lenses (Models SN60AT, SA60AT, SN60WF, SA60WF, SN6AT3-T9) at the Alcon Cork, Ireland manufacturing facility.

Current openFDA PMA Record#

Device
AcrySof IQ ReSTOR Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S083
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2018-10-11
Decision code
OK30
Date received
2018-09-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modifications to the control and monitoring program of the Environmental Controlled Areas for the AcrySof® IQ ReSTOR® Intraocular Lenses (Model Number, SN6AD1) and the AcrySof® Single Piece Intraocular Lenses (Models SN60AT, SA60AT, SN60WF, SA60WF, SN6AT3-T9) at the Alcon Cork, Ireland manufacturing facility.