BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1772254 · Received July 22, 2010

    Report

    Report Number
    2028159-2010-01274
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 22, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION, INCLUDING ROOT CAUSE DETERMINATION, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "SIGNIFICANT WOUND BURN." (BURN, CORNEAL) PRODUCT PROBLEM(S): "NO REPORTED DEVICE PROBLEM." (NO KNOWN DEVICE PROBLEM). LOCAL MEDICAL SAFETY SPECIALIST REPORTED THAT A WOUND BURN OCCURRED DURING CATARACT SURGERY, BEFORE CRACKING. THE NUCLEUS WAS HARD AND SURGEON WAS USING 100% US. THE SURGEON WAS WORKING UNDER MICROSCOPE AND THE INCISION SITE WAS NOT IN THE MICROSCOPE'S FIELD OF VISION, SO SURGEON DID NOT SEE THE CORNEA BECOMING WHITISH. THE WOUND BURN WAS ABOUT 2MM BY 2 AND AFFECTED TWO-THIRDS OF THE SCLERAL TUNNEL INCISION. THE CLINICAL CONSEQUENCES WERE: SIGNIFICANT ASTIGMATISM, INCISION WAS NOT TIGHT, TISSUES WERE RETRACTED AND DESCEMET'S MEMBRANE FOLDED. NO SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 20000 LEGACY PHACOFRAGMENTATON SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention