PMA P040045S141

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: S141
Product code: LPM
Decision date: 2025-12-16
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: an update to the control plan for material characteristics for the Vistakon (senofilcon A) and (etafilcon A) Brand Contact Lenses

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: S141
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2025-12-16
Decision code: OK30
Date received: 2025-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an update to the control plan for material characteristics for the Vistakon (senofilcon A) and (etafilcon A) Brand Contact Lenses