PMA P010019S075

Device: Lotrafilcon A and B Soft contact lenses for extended wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S075
Product code: LPM
Decision date: 2020-01-22
Generic name: Lenses, soft contact, extended wear
Approval order statement: Addition of an alternate raw material supplier for the polypropylene resin used in the fabrication of molds for producing class III lotrafilcon A and B soft contact lenses for extended wear.

Current openFDA PMA Record#

Device: Lotrafilcon A and B Soft contact lenses for extended wear
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S075
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2020-01-22
Decision code: OK30
Date received: 2019-12-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate raw material supplier for the polypropylene resin used in the fabrication of molds for producing class III lotrafilcon A and B soft contact lenses for extended wear.