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XEN 45 GTS (AUSTRALIA) Adverse Event — Injury (MDR 3011299751-2020-00182)

XEN 45 GTS (AUSTRALIA) Adverse Event — Injury (MDR 3011299751-2020-00182) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: XEN 45 GTS (AUSTRALIA); Generic name: IMPLANT, EYE VALVE; Manufacturer: ALLERGAN (IRVINE).

DeviceXEN 45 GTS (AUSTRALIA)
Generic nameIMPLANT, EYE VALVE
ManufacturerALLERGAN (IRVINE)
Report number3011299751-2020-00182
Event typeInjury
Product problemN
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE, FOREIG
NarrativeTHE EVENTS OF UVEITIS, HYPHEMA, AND OCULAR PAIN ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
SourceopenFDA MAUDE (device adverse events)

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