BIOFINITY SPHERE (COMFILCON A)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-21 for BIOFINITY SPHERE (COMFILCON A) manufactured by Coopervision Manufacturing, Ltd..

MAUDE Entry Details

Report Number9614392-2019-00032
MDR Report Key9354766
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-21
Date of Report2019-11-21
Date of Event2019-10-12
Date Mfgr Received2019-10-22
Date Added to Maude2019-11-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MELISSA TORPEY
Manufacturer Street5870 STONERIDGE DRIVE SUITE 1
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal94588
Manufacturer Phone5857569874
Manufacturer G1COOPERVISION MANUFACTURING, LTD.
Manufacturer StreetSOUTH POINT HAMBLE UNIT 2
Manufacturer CitySOUTHAMPTOM, HAMPSHIRE SO314RF
Manufacturer CountryUK
Manufacturer Postal CodeSO31 4RF
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOFINITY SPHERE (COMFILCON A)
Generic NameBIOFINITY SPHERE (COMFILCON A)
Product CodeLPM
Date Received2019-11-21
Lot Number11319050089014
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOPERVISION MANUFACTURING, LTD.
Manufacturer AddressSOUTH POINT HAMBLE UNIT 2 SOUTHAMPTOM, HAMPSHIRE SO314RF UK SO31 4RF


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit 2019-11-21

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