BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 624393 · Received July 14, 2005

    Report

    Report Number
    2028159-2005-00109
    Event Type
    Malfunction
    Date Received
    July 14, 2005
    Date of Event
    June 13, 2005
    Report Date
    June 14, 2005
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED POSTERIOR CAPSULE WAS TORN BY TIP AT VERY BEGINNING OF I/A. NO VITRECTOMY REQUIRED. OUTCOME REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR