PMA P010019S074

Device: Lotrafilcon B soft contact lenses for extended wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S074
Product code: LPM
Decision date: 2019-12-12
Generic name: Lenses, soft contact, extended wear
Approval order statement: Extension of the lotrafilcon B soft contact lens manufacturing operations at the Alcon Batam, Indonesia production site for inclusion of AIR OPTIX plus Hydraglyde (lotrafilcon B) spherical soft contact lenses.

Current openFDA PMA Record#

Device: Lotrafilcon B soft contact lenses for extended wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S074
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-12-12
Decision code: OK30
Date received: 2019-11-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Extension of the lotrafilcon B soft contact lens manufacturing operations at the Alcon Batam, Indonesia production site for inclusion of AIR OPTIX plus Hydraglyde (lotrafilcon B) spherical soft contact lenses.