PMA P040045

Device: VISTAKON® (senofilcon A) Brand Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S129
Product code: LPM
Decision date: 2026-10-16
Generic name: Lenses, soft contact, extended wear
Approval order statement: addition of alternate raw material supplier for the color additive used in the manufacturing process for Vistakon (senofilcon A) Brand Contact Lenses for lens visible handling, at the manufacturing facilities located in Jacksonville, Florida and Limerick, Ireland

Current openFDA PMA Record#

Device: VISTAKON® (senofilcon A) Brand Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S147
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-10-16
Decision code: OK30
Date received: 2026-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of alternate raw material supplier for the color additive used in the manufacturing process for Vistakon (senofilcon A) Brand Contact Lenses for lens visible handling, at the manufacturing facilities located in Jacksonville, Florida and Limerick, Ireland