BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPRISM

    MDR report key: 3748361 · Received April 3, 2014

    Report

    Report Number
    3014865-2014-00001
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 1, 2014
    Manufacturer
    OCULAR INSTRUMENTS
    Product Code
    HKS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ENDOPHTHALMITIS IN THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200253 IPRISM GONIOPRISM HKS OCULAR INSTRUMENTS 10820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention| S ISTENT