BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 851533 · Received May 16, 2007

    Report

    Report Number
    2028159-2007-00250
    Event Type
    Malfunction
    Date Received
    May 16, 2007
    Date of Event
    February 12, 2007
    Report Date
    March 27, 2007
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A LETTER AND COPY OF AN INDUSTRY ARTICLE (ECRI HEALTH DEVICES, HAZARD UPDATE: SCLERAL AND CORNEAL BURNS DURING PHACOEMULSIFICATION, IN 1996, VOL. 25, NO. 11: 426-431) WHICH DESCRIBES FACTORS THAT WOULD INCREASE TEMPERATURE AT THE INCISION WAS PROVIDED TO THE CUSTOMER. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. THIS REPORT MAILED IN TO FDA ON: 05/16/2007.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A CORNEAL BURN OCCURRED DURING A CASE. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR