PMA P010019S054

Device: AIR OPTIX plus HYDRAGLYDE Soft Contact Lenses for Daily and Extended Wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S054
Product code: LPM
Decision date: 2017-04-21
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Update to the variable sampling plan for the lens power testing during in-process and final product quality control testing of AIR OPTIX plus HydraGlyde (lotrafilcon B) soft contact lenses for daily and extended wear.

Current openFDA PMA Record#

Device: AIR OPTIX plus HYDRAGLYDE Soft Contact Lenses for Daily and Extended Wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S054
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2017-04-21
Decision code: OK30
Date received: 2017-03-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Update to the variable sampling plan for the lens power testing during in-process and final product quality control testing of AIR OPTIX plus HydraGlyde (lotrafilcon B) soft contact lenses for daily and extended wear.