PMA P010019S056

Device: AIR, OPTIX, AQUA, MULTIFOCAL (lotrafilcon B) Soft Contact Lenses for daily and extended wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S056
Product code: LPM
Decision date: 2017-09-05
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Update to the device quality control testing by changing the in-process inspection of lens power, lens optical quality and lens diameter for AIR OPTIX AQUA MULTIFOCAL (lotrafilcon B) soft contact lenses.

Current openFDA PMA Record#

Device: AIR, OPTIX, AQUA, MULTIFOCAL (lotrafilcon B) Soft Contact Lenses for daily and extended wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S056
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2017-09-05
Decision code: OK30
Date received: 2017-08-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Update to the device quality control testing by changing the in-process inspection of lens power, lens optical quality and lens diameter for AIR OPTIX AQUA MULTIFOCAL (lotrafilcon B) soft contact lenses.