PMA P080011S189

Device: comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S189
Product code: LPM
Decision date: 2025-06-23
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: modify the manufacturing process to extend the shelf-life of NVP materials from 3 months to 6 months and remove the retest requirement at CooperVision’smanufacturing facilities located in Hamble, UK, Scottsville, NY, and Juana Diaz, PR

Current openFDA PMA Record#

Device: comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S189
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2025-06-23
Decision code: OK30
Date received: 2025-06-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modify the manufacturing process to extend the shelf-life of NVP materials from 3 months to 6 months and remove the retest requirement at CooperVision’smanufacturing facilities located in Hamble, UK, Scottsville, NY, and Juana Diaz, PR