PMA P080011S137

Device: Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S137
Product code: LPM
Decision date: 2022-01-06
Generic name: Lenses, soft contact, extended wear
Approval order statement: Modification to the lens transfer process for the Biofinity XR Toric product at the CooperVision Manufacturing Ltd. facility in Hamble, United Kingdom.

Current openFDA PMA Record#

Device: Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S137
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-01-06
Decision code: OK30
Date received: 2021-12-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification to the lens transfer process for the Biofinity XR Toric product at the CooperVision Manufacturing Ltd. facility in Hamble, United Kingdom.