PMA P010019S086

Device: Air Optix Plus Hydraglyde (lotrafilcon B) Spherical and Multifocal Soft Contact Lenses for Extended Wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S086
Product code: LPM
Decision date: 2026-02-26
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: Implementation of an Automated Wet Inspection System (AWIS) to be used as an alternative to the currently practiced 100% manual inspection for the Air Optix Plus Hydraglyde (lotrafilcon B) spherical and multifocal soft contact lenses for extended wear at the Ciba Vision Johor, Malaysia facility.

Current openFDA PMA Record#

Device: Air Optix Plus Hydraglyde (lotrafilcon B) Spherical and Multifocal Soft Contact Lenses for Extended Wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S086
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-02-26
Decision code: OK30
Date received: 2026-01-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of an Automated Wet Inspection System (AWIS) to be used as an alternative to the currently practiced 100% manual inspection for the Air Optix Plus Hydraglyde (lotrafilcon B) spherical and multifocal soft contact lenses for extended wear at the Ciba Vision Johor, Malaysia facility.