BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAOCULAR LENS

    MDR report key: 19243 · Received January 30, 1995

    Report

    Report Number
    MW1004915
    Event Type
    Malfunction
    Date Received
    January 30, 1995
    Date of Event
    November 14, 1994
    Report Date
    January 17, 1995
    Manufacturer
    ALLERGAN MEDICAL OPTICS
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS INSERTING FOLDABLE INTRAOCULAR LENS INTO EYE, WHEN IT BROKE IN HALF. HE WAS ABLE TO REMOVE LENS WITH NO PROBLEM TO PT. THE COMPANY AND REPRESENTATIVE WERE NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAOCULAR LENS INTRAOCULAR LENS HQL ALLERGAN MEDICAL OPTICS SI30NB

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other