PMA P040045S143

Device: VISTAKON® (senofilcon A) Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S143
Product code: LPM
Decision date: 2026-04-29
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: qualification of an additional production line (TAM 27), with changeover capability, to produce Vistakon (senofilcon A) contact lenses at the Johnson & Johnson Vision Care manufacturing facility located in Jacksonville, Florida

Current openFDA PMA Record#

Device: VISTAKON® (senofilcon A) Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S143
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-04-29
Decision code: OK30
Date received: 2026-04-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: qualification of an additional production line (TAM 27), with changeover capability, to produce Vistakon (senofilcon A) contact lenses at the Johnson & Johnson Vision Care manufacturing facility located in Jacksonville, Florida