FDA.reportPublic FDA data

PMA P040020S097

Device
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S097
Product code
MFK
Decision date
2020-12-17
Generic name
Lens, multifocal intraocular
Approval order statement
Introduction of the Turbidimetric Test Method for the Detection of Endotoxin levels for PMMA, AcrySof and AcrySof ReSTOR Intraocular Lenses (IOLs), AcrySert and UltraSert Lens Delivery Systems and Purified Water at Alcon Huntington West Virginia.

Current openFDA PMA Record#

Device
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens
Applicant
Alcon Research, Ltd.
PMA number
P040020
Supplement
S097
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2020-12-17
Decision code
OK30
Date received
2020-11-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of the Turbidimetric Test Method for the Detection of Endotoxin levels for PMMA, AcrySof and AcrySof ReSTOR Intraocular Lenses (IOLs), AcrySert and UltraSert Lens Delivery Systems and Purified Water at Alcon Huntington West Virginia.