BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL

    MDR report key: 444008 · Received February 14, 2003

    Report

    Report Number
    1644019-2003-00004
    Event Type
    Malfunction
    Date Received
    February 14, 2003
    Date of Event
    March 25, 2002
    Report Date
    January 17, 2003
    Manufacturer
    ALCON - HOUSTON
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED PT HAS COMPLAINED OF PHOTOPHOBIA AND ASTHENOPIA. METALLIC FOREIGN BODIES WERE OBSERVED ON IRIS THREE MONTHS POST-OP. NO INFLAMMATION IN ANTERIOR CHAMBER. SURGEON PLANS TO RE-OPERATE. FEELS PARTICLES MAY BE THE RESULT OF CONTACT OF U/S TIP WITH PHACO CHOPPER DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL OPHTHALMIC SURGERY SYSTEM HQE ALCON - HOUSTON UNIVERSAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR