FDA.reportPublic FDA data

PMA P080011S095

Device
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S095
Product code
LPM
Decision date
2019-08-09
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Software update to the wet Automated Inspection System (AIS) used for Biofinity (comfilcon A) soft (hydrophilic) extended wear contact lenses manufactured at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom.

Current openFDA PMA Record#

Device
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S095
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2019-08-09
Decision code
OK30
Date received
2019-07-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Software update to the wet Automated Inspection System (AIS) used for Biofinity (comfilcon A) soft (hydrophilic) extended wear contact lenses manufactured at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom.