BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 17626 · Received September 28, 1994

    Report

    Report Number
    17626
    Event Type
    Injury
    Date Received
    September 28, 1994
    Date of Event
    August 19, 1994
    Report Date
    September 28, 1994
    Manufacturer
    UNKNOWN
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IOL REMOVED 8/19/94 FROM PT'S RIGHT EYE FOR PRESUMED PSEUDOPHAKIC BULLOUS KERATOPATHY AND CORNEAL DECOMPENSATION. PBK WAS CONFIRMED BY PATHOLOGY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN Implant LEISKE-STYLE IOL HQL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention