PMA P010019S044

Device: LOTRAFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S044
Product code: LPM
Decision date: 2016-02-23
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Move manufacturing of semi-finished subassemblies for the Alcon class III Lotrafilcon A Soft Contact Lens from Duluth, Georgia, USA to Johor Malaysia.

Current openFDA PMA Record#

Device: LOTRAFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S044
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2016-02-23
Decision code: OK30
Date received: 2016-01-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Move manufacturing of semi-finished subassemblies for the Alcon class III Lotrafilcon A Soft Contact Lens from Duluth, Georgia, USA to Johor Malaysia.