PMA N18033S113

Device: VISTAKON® (etafilcon A) lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S113
Product code: LPM
Decision date: 2026-03-10
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: implementation of Cooper Tungsten (CuW) heat seal die plates for the production of Vistakon (etafilcon A) Brand Contact Lenses on Line 30 at the Limerick, Ireland manufacturing facility

Current openFDA PMA Record#

Device: VISTAKON® (etafilcon A) lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S113
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-03-10
Decision code: OK30
Date received: 2026-02-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of Cooper Tungsten (CuW) heat seal die plates for the production of Vistakon (etafilcon A) Brand Contact Lenses on Line 30 at the Limerick, Ireland manufacturing facility