PMA P010019S048

Device: FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S048
Product code: LPM
Decision date: 2016-03-23
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Installation and qualification of a new water pre-treatment and a new USP purified water system used in the production of USP purified water at the Batam, Indonesia manufacturing site.

Current openFDA PMA Record#

Device: FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S048
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2016-03-23
Decision code: OK30
Date received: 2016-03-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Installation and qualification of a new water pre-treatment and a new USP purified water system used in the production of USP purified water at the Batam, Indonesia manufacturing site.