PMA P010019S061

Device: AIR OPTIX plus HydraGlyde (lotrafilcon B) Soft Contact Lenses for Daily and Extedned Wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S061
Product code: LPM
Decision date: 2017-11-13
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Transfer of a raw material pelletization process from in-house to an external supplier and establishing a 3-year shelf life for the raw material based on a stability study completed, thereby removing the periodic material retesting requirement for stability confirmation.

Current openFDA PMA Record#

Device: AIR OPTIX plus HydraGlyde (lotrafilcon B) Soft Contact Lenses for Daily and Extedned Wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S061
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2017-11-13
Decision code: OK30
Date received: 2017-10-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Transfer of a raw material pelletization process from in-house to an external supplier and establishing a 3-year shelf life for the raw material based on a stability study completed, thereby removing the periodic material retesting requirement for stability confirmation.