MILOOP LENS FRAGMENTATION DEVICE FG-11881

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-11 for MILOOP LENS FRAGMENTATION DEVICE FG-11881 manufactured by Carl Zeiss Meditec Cataract Technology, Inc..

MAUDE Entry Details

Report Number3012123033-2019-00007
MDR Report Key8996817
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-09-11
Date of Report2019-10-15
Date of Event2019-08-12
Date Mfgr Received2019-09-30
Device Manufacturer Date2019-03-19
Date Added to Maude2019-09-11
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 ContactED CONLEY
Manufacturer Street8748 TECHNOLOGY WAY
Manufacturer CityRENO NV 89521
Manufacturer CountryUS
Manufacturer Postal89521
Manufacturer Phone7753797261
Manufacturer G1CARL ZEISS MEDITECH CATARACT TECHNOLOGY, INC.
Manufacturer Street8748 TECHNOLOGY WAY
Manufacturer CityRENO NV 89521
Manufacturer CountryUS
Manufacturer Postal Code89521
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMILOOP LENS FRAGMENTATION DEVICE
Generic NameOPHTHALMIC HOOK
Product CodeHNQ
Date Received2019-09-11
Returned To Mfg2019-08-19
Model NumberFG-11881
Lot NumberFG19031910
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC.
Manufacturer Address8748 TECHNOLOGY WAY RENO NV 89521 US 89521


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-09-11

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