PMA P000030S002

Device: FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P000030
Supplement: S002
Product code: LPM
Decision date: 2016-03-23
Generic name: Lenses, soft contact, extended wear
Approval order statement: Manufacturing changes to include the installation and qualification of new (i.e., replacement) systems for the production of phosphate buffered saline and for the production of phosphate buffered saline with hydrogen peroxide at the Batam, Indonesia production facility.

Current openFDA PMA Record#

Device: FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P000030
Supplement: S002
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2016-03-23
Decision code: OK30
Date received: 2016-02-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing changes to include the installation and qualification of new (i.e., replacement) systems for the production of phosphate buffered saline and for the production of phosphate buffered saline with hydrogen peroxide at the Batam, Indonesia production facility.