PMA P810032

Device: PMMA Multiple and Single-Piece Posterior Chamber IOLs
Applicant: Alcon Laboratories
PMA number: P810032
Supplement: S070
Product code: HQL
Decision date: 2024-06-20
Classification: Intraocular Lens
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 Multiple and Single-Piece Posterior Chamber IOLs
Applicant: Alcon Laboratories
PMA number: P810032
Supplement: S071
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