FDA.reportPublic FDA data

PMA P080011S133

Device
Biofinity XR Toric, Biofinity Toric Multifocal
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S133
Product code
LPM
Decision date
2021-11-17
Generic name
Lenses, soft contact, extended wear
Approval order statement
Introduction of a new lathing execution software system for Biofinity XR Toric and Biofinity Toric Multifocal products at the CooperVision Manufacturing Ltd. facility in Hamble, UK.

Current openFDA PMA Record#

Device
Biofinity XR Toric, Biofinity Toric Multifocal
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S133
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2021-11-17
Decision code
OK30
Date received
2021-10-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of a new lathing execution software system for Biofinity XR Toric and Biofinity Toric Multifocal products at the CooperVision Manufacturing Ltd. facility in Hamble, UK.