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PMA P880087S030

Device
PMMA Single-Piece Anterior Chamber Intraocular Lens
Applicant
Alcon Laboratories
PMA number
P880087
Supplement
S030
Product code
HQL
Decision date
2020-12-17
Generic name
intraocular lens
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
PMMA Single-Piece Anterior Chamber Intraocular Lens
Applicant
Alcon Laboratories
PMA number
P880087
Supplement
S030
Product code
HQL
Generic name
intraocular lens
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.