PMA N18033S114

Device: VISTAKON® (etafilcon A) Brand Contact Lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S114
Product code: LPM
Decision date: 2026-04-17
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: addition of an alternate raw supplier for subcomponent, Reactive Blue No. 4 (RB4), used in the production of Vistakon (senofilcon A) and Vistakon (etafilcon A) Brand Contact Lenses at the Jacksonville, Florida and Limerick, Ireland manufacturing facilities

Current openFDA PMA Record#

Device: VISTAKON® (etafilcon A) Brand Contact Lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S114
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-04-17
Decision code: OK30
Date received: 2026-03-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of an alternate raw supplier for subcomponent, Reactive Blue No. 4 (RB4), used in the production of Vistakon (senofilcon A) and Vistakon (etafilcon A) Brand Contact Lenses at the Jacksonville, Florida and Limerick, Ireland manufacturing facilities