BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGEN

    MDR report key: 73546 · Received January 22, 1997

    Report

    Report Number
    73546
    Event Type
    Injury
    Date Received
    January 22, 1997
    Date of Event
    April 8, 1996
    Report Date
    July 2, 1996
    Manufacturer
    AMD
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH POOR VISION AND PAIN IN RIGHT EYE. ANTERIOR CHAMBER INTRAOCULAR LENS, PLACED IN 1990, WAS SUBLUXED WITH RESULTING UVEITIS. SURGERY WAS PERFORMED TO REMOVE THE LENS AND THUS PREVENTING THE PROGRESSION OF UVEITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGEN Implant INTRAOCULAR LENS HQL AMD ACZIB *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R