PMA P000030S001

Device: FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P000030
Supplement: S001
Product code: LPM
Decision date: 2016-03-14
Generic name: Lenses, soft contact, extended wear
Approval order statement: Revision of internal procedures to harmonize the nomenclature for identifying the tooling used to manufacture approved contact lenses at the Johor and Atlanta manufacturing facilities; and development and implementation of a plan to validate and verify the fabrication of Lotrafilcon B Toric optical tools at the Johor manufacturing facility.

Current openFDA PMA Record#

Device: FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P000030
Supplement: S001
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2016-03-14
Decision code: OK30
Date received: 2016-02-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Revision of internal procedures to harmonize the nomenclature for identifying the tooling used to manufacture approved contact lenses at the Johor and Atlanta manufacturing facilities; and development and implementation of a plan to validate and verify the fabrication of Lotrafilcon B Toric optical tools at the Johor manufacturing facility.