BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EYE PACK STANDARD-LF

    MDR report key: 1908339 · Received November 18, 2010

    Report

    Report Number
    1417592-2010-00069
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    September 23, 2010
    Report Date
    November 9, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON WAS DOING A CATARACT PROCEDURE AND REPORTED SEEING BLUE SMOOTH FILAMENTS IN THE PT'S EYE. THESE WERE SEEN WHEN USING THE MICROSCOPIC EQUIPMENT THAT IS USED DURING THE PROCEDURE. THE PT RETURNED FOR A SECOND PROCEDURE TO REMOVE BLUE PARTICLES AFTER INFLAMMATION DEVELOPED. THE PT WAS REPORTED TO BE DOING WELL AND NO FURTHER COMPLICATIONS WERE REPORTED. THE SOURCE OF THE FILAMENTS IS NOT KNOWN. NO SAMPLE WAS RETAINED FOR EVAL AND THE LOT NUMBER IS NOT KNOWN. THE SURGEON THEORIZED THAT THE SOURCE OF THE FILAMENTS WAS THE BOWL. RANDOMLY PULLED SAMPLES OF THE BLUE PLASTIC COMPONENTS IN THE PACK INCLUDING THE BOWL AND 2-COMPARTMENT TRAY. THEY WERE VISUALLY INSPECTED. THEY WERE THEN INSPECTED USING AN EYE LOOP WITH NO DEFECTS OR ABNORMALITIES DETECTED. A ROOT CAUSE HAS NOT BEEN DETERMINED. HOWEVER, DUE TO THE REPORTED INCIDENT AND NEED FOR SURGICAL INTERVENTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    A PT REQUIRED A SURGICAL PROCEDURE TO REMOVE BLUE FILAMENTS FROM THE EYE FOLLOWING A CATARACT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EYE PACK STANDARD-LF NONE OJK MEDLINE INDUSTRIES, INC. DYNJS0120 UNK MEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention