PMA P010019S076

Device: Lotrafilcon A Soft Contact Lenses and Lotrafilcon B Soft Contact Lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S076
Product code: LPM
Decision date: 2020-03-19
Generic name: Lenses, soft contact, extended wear
Approval order statement: Addition of an alternate polypropylene resin and supplier used in the blister shells for primary packaging of lotrafilcon A and B extended wear soft contact lenses.

Current openFDA PMA Record#

Device: Lotrafilcon A Soft Contact Lenses and Lotrafilcon B Soft Contact Lenses
Applicant: Alcon Laboratories, Inc.
PMA number: P010019
Supplement: S076
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2020-03-19
Decision code: OK30
Date received: 2020-02-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate polypropylene resin and supplier used in the blister shells for primary packaging of lotrafilcon A and B extended wear soft contact lenses.