PMA P040045

Device: VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S129
Product code: LPM
Decision date: 2026-09-02
Generic name: Lenses, soft contact, extended wear
Approval order statement: qualification of an existing manufacturing line to produce VISTAKON (senofilcon A) contact lenses, at the manufacturing facility located in Jacksonville, Florida

Current openFDA PMA Record#

Device: VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S145
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-09-02
Decision code: OK30
Date received: 2026-08-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: qualification of an existing manufacturing line to produce VISTAKON (senofilcon A) contact lenses, at the manufacturing facility located in Jacksonville, Florida