PMA P180035S013

Device: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant: CooperVision, Inc.
PMA number: P180035
Supplement: S013
Product code: QIT
Decision date: 2023-01-12
Generic name: Daily wear soft contact lens to reduce the progression of myopia
Approval order statement: Manufacture of MiSight 1 Day (omafilcon A) product on Dry Line HD and Wet Line HVD at the Warrior Close manufacturing facility in Chandler's Ford, Eastleigh, UK.

Current openFDA PMA Record#

Device: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant: CooperVision, Inc.
PMA number: P180035
Supplement: S013
Product code: QIT
Generic name: Daily wear soft contact lens to reduce the progression of myopia
Decision date: 2023-01-12
Decision code: OK30
Date received: 2022-12-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacture of MiSight 1 Day (omafilcon A) product on Dry Line HD and Wet Line HVD at the Warrior Close manufacturing facility in Chandler's Ford, Eastleigh, UK.