PMA P810032S070

Device: PMMA Multi-Piece Posterior Chamber Intraocular Lens
Applicant: Alcon Laboratories
PMA number: P810032
Supplement: S070
Product code: HQL
Decision date: 2019-08-01
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Addition of a 100% Ethylene Oxide (EO) sterilization chamber, integrated aeration cell, and supporting equipment at the Alcon Huntington manufacturing facility.

Current openFDA PMA Record#

Device: PMMA Multi-Piece Posterior Chamber Intraocular Lens
Applicant: Alcon Laboratories
PMA number: P810032
Supplement: S070
Product code: HQL
Generic name: intraocular lens
Decision date: 2019-08-01
Decision code: OK30
Date received: 2019-07-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a 100% Ethylene Oxide (EO) sterilization chamber, integrated aeration cell, and supporting equipment at the Alcon Huntington manufacturing facility.