PMA P010019S081

Device: AIR OPTIX NIGHT & DAY AQUA, AIR OPTIX AQUA, AIR OPTIX AQUA MULTIFOCAL, AIR OPTIX Plus HYDRAGLYDE, AIR OPTIX Plus HYDRAGL
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S081
Product code: LPM
Decision date: 2022-01-12
Generic name: Lenses, soft contact, extended wear
Approval order statement: Moving the 'lens rinsing' process step to an earlier position of the manufacturing process flow for production of lotrafilcon A and B material soft contact lenses for extended wear at the Alcon Batam, lndonesia facility.

Current openFDA PMA Record#

Device: AIR OPTIX NIGHT & DAY AQUA, AIR OPTIX AQUA, AIR OPTIX AQUA MULTIFOCAL, AIR OPTIX Plus HYDRAGLYDE, AIR OPTIX Plus HYDRAGL
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S081
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-01-12
Decision code: OK30
Date received: 2021-12-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Moving the 'lens rinsing' process step to an earlier position of the manufacturing process flow for production of lotrafilcon A and B material soft contact lenses for extended wear at the Alcon Batam, lndonesia facility.