PMA P010019S079

Device: Lotrafilcon A and B soft contact lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S079
Product code: LPM
Decision date: 2021-09-10
Generic name: Lenses, soft contact, extended wear
Approval order statement: Decommissioning of the strip blister inspection system (SBI) at the packaging lines in the production of Alcon lotrafilcon A and lotrafilcon B soft contact lenses for daily and extended wear.

Current openFDA PMA Record#

Device: Lotrafilcon A and B soft contact lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S079
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2021-09-10
Decision code: OK30
Date received: 2021-08-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Decommissioning of the strip blister inspection system (SBI) at the packaging lines in the production of Alcon lotrafilcon A and lotrafilcon B soft contact lenses for daily and extended wear.