PMA P880087

Device
PMMA Single-Piece Anterior Chamber IOL
Applicant
Alcon Laboratories
PMA number
P880087
Supplement
S031
Product code
HQL
Decision date
2024-06-20
Generic name
intraocular lens
Approval order statement
removing the redundant Melting Point Test from three raw material incoming inspection criteria for IOLs manufactured at Alcon Huntington, West Virginia

Current openFDA PMA Record#

Device
PMMA Single-Piece Anterior Chamber IOL
Applicant
Alcon Laboratories
PMA number
P880087
Supplement
S033
Product code
HQL
Generic name
intraocular lens
Decision date
2024-06-20
Decision code
OK30
Date received
2024-06-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
removing the redundant Melting Point Test from three raw material incoming inspection criteria for IOLs manufactured at Alcon Huntington, West Virginia