PMA P010019S073

Device: Lotrafilcon A and B Soft Contact Lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S073
Product code: LPM
Decision date: 2019-08-30
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Qualification of a new X-Ray Photoelectron Spectrophotometer used for the measurement of lens plasma coating during in-process quality control inspection 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: S073
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-08-30
Decision code: OK30
Date received: 2019-08-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of a new X-Ray Photoelectron Spectrophotometer used for the measurement of lens plasma coating during in-process quality control inspection in the production of Alcon lotrafilcon A and lotrafilcon B soft contact lenses for daily and extended wear.