PMA P040020S071

Device
AcrySof® IQ ReSTOR® Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S071
Product code
MFK
Decision date
2018-01-23
Classification
Lens, Multifocal Intraocular
Generic name
Lens, multifocal intraocular
Approval order statement
Approval for the use of the membrane filtration bioburden recovery method for the AcrySof Intraocular Lenses.

Current openFDA PMA Record#

Device
AcrySof® IQ ReSTOR® Intraocular Lenses
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S071
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2018-01-23
Decision code
APPR
Date received
2017-06-15
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the use of the membrane filtration bioburden recovery method for the AcrySof Intraocular Lenses.