PMA P180035

Device: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant: CooperVision, Inc.
PMA number: P180035
Supplement: S015
Product code: QIT
Decision date: 2026-02-17
Generic name: Daily wear soft contact lens to reduce the progression of myopia
Approval order statement: introduction of a secondary packaging line within the CooperVision, Inc. facility in West Henrietta, New York

Current openFDA PMA Record#

Device: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant: CooperVision, Inc.
PMA number: P180035
Supplement: S034
Product code: QIT
Generic name: Daily wear soft contact lens to reduce the progression of myopia
Decision date: 2026-02-17
Decision code: OK30
Date received: 2026-01-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introduction of a secondary packaging line within the CooperVision, Inc. facility in West Henrietta, New York