BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 49182 · Received November 12, 1996

    Report

    Report Number
    49182
    Event Type
    Injury
    Date Received
    November 12, 1996
    Date of Event
    September 26, 1996
    Report Date
    November 12, 1996
    Manufacturer
    UNK
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IRIS PLANE IOL WHICH CAME IN INTERMITTENT CONTACT WITH CORNEA. PT DEVELOPED PSEUDOPHAKIC BULLOUS KERATOPATHY (PBK) NECESSITATING PENETRATING KERATOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant IRIS PLANE IOL HQL UNK UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention| S