PMA P080011S149

Device: Biofinity Toric (comfilcon A) soft (hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S149
Product code: LPM
Decision date: 2022-10-26
Generic name: Lenses, soft contact, extended wear
Approval order statement: Modification to optimize the lens transfer module of the manufacturing process for the Biofinity Toric at the CooperVision manufacturing Puerto Rico LLC Juana Diaz facility.

Current openFDA PMA Record#

Device: Biofinity Toric (comfilcon A) soft (hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S149
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-10-26
Decision code: OK30
Date received: 2022-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification to optimize the lens transfer module of the manufacturing process for the Biofinity Toric at the CooperVision manufacturing Puerto Rico LLC Juana Diaz facility.