PMA P040045S146

Device: VISTAKON (SENOFILCON A) Brand Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S146
Product code: LPM
Decision date: 2026-10-08
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: qualification of an alternate heat-sealing system in an existing manufacturing line to produce VISTAKON (senofilcon A) contact lenses, at the manufacturing facility located in 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: S146
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-10-08
Decision code: OK30
Date received: 2026-09-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: qualification of an alternate heat-sealing system in an existing manufacturing line to produce VISTAKON (senofilcon A) contact lenses, at the manufacturing facility located in Limerick, Ireland