PMA N18033S110

Device: VISTAKON (etafilcon A) Brand Contact Lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S110
Product code: LPM
Decision date: 2022-12-16
Generic name: Lenses, soft contact, extended wear
Approval order statement: Alternate supplier for a raw material used in the production of lens molds for the manufacturing process of VISTAKON (etafilcon A) Brand Contact Lenses.

Current openFDA PMA Record#

Device: VISTAKON (etafilcon A) Brand Contact Lenses
Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.
PMA number: N18033
Supplement: S110
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-12-16
Decision code: OK30
Date received: 2022-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternate supplier for a raw material used in the production of lens molds for the manufacturing process of VISTAKON (etafilcon A) Brand Contact Lenses.