PMA P040045S126

Device: VISTAKON (senofilcon A) Brand Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S126
Product code: LPM
Decision date: 2022-06-22
Generic name: Lenses, soft contact, extended wear
Approval order statement: Implementation of a new test method for measurement of leachable components in VISTAKON® (senofilcon A) Brand Contact Lenses.

Current openFDA PMA Record#

Device: VISTAKON (senofilcon A) Brand Contact Lenses
Applicant: Vistakon, Division of Johnson & Johnson Vision Car
PMA number: P040045
Supplement: S126
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-06-22
Decision code: OK30
Date received: 2022-05-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a new test method for measurement of leachable components in VISTAKON® (senofilcon A) Brand Contact Lenses.