CLARITI 1 DAY SPHERE (SOMOFILCON A)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-13 for CLARITI 1 DAY SPHERE (SOMOFILCON A) manufactured by Coopervision Cl Kft.

MAUDE Entry Details

Report Number3009108089-2019-00013
MDR Report Key9319488
Report SourceDISTRIBUTOR
Date Received2019-11-13
Date of Report2019-11-13
Date of Event2019-10-13
Date Mfgr Received2019-10-14
Date Added to Maude2019-11-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 CL KFT
Manufacturer StreetH-2360 GYAL PROLOGIA UZLETI PARK, 3 EP
Manufacturer CityGYAL, 7100
Manufacturer CountryHU
Manufacturer Postal Code7100
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLARITI 1 DAY SPHERE (SOMOFILCON A)
Generic NameCLARITI 1 DAY SPHERE (SOMOFILCON A)
Product CodeMVN
Date Received2019-11-13
Returned To Mfg2019-10-22
Lot NumberV0073471
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOPERVISION CL KFT
Manufacturer AddressH-2360 GYAL PROLOGIA UZLETI PARK, 3 EP GYAL, 7100 HU 7100


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-13

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