BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 1140049 · Received August 28, 2008

    Report

    Report Number
    3002037047-2008-00064
    Event Type
    Injury
    Date Received
    August 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ALCON-BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: THE COTTON SWABS ARE LYING IN THE MEDICINE CUP, WITHOUT BEING WRAPPED OR PACKAGED. THE NURSE REMOVES THE SWABS FROM THE CUP, AND FILLS THE CUP WITH BSS, THE BSS IS DRAWN UP INTO A SYRINGE WHICH IS USED FOR IRRIGATION AND INFLATING THE ANTERIOR CHAMBER AS NEEDED DURING THE PROCEDURE. IT IS THOUGHT THAT FLUFFS (FIBERS) FROM THE SWABS COME TOGETHER WITH THE BSS SOLUTION IN THE SYRINGE AND ALSO INTO THE PT'S EYE. THE SURGEON REPORTS THAT HE CANNOT SEE THE FIBERS UNDER THE MICROSCOPE, BUT THE "PARTICLES" CAN BE SEEN IN THE EYE DURING THE FOLLOW-UP EXAMINATION. THE SURGEON REPORTED THAT HE HAD TO REMOVE THE FIBERS IN A FEW CASES DURING A SECOND SURGERY. ADD'L INFO RECEIVED. THE SURGEON STATED THAT THE PTS DID NOT NOTICE THE FIBERS (AND IT WAS NOT VISIBLE UNDER THE MICROSCOPE DURING SURGERY), BUT IT WAS DETECTED WITH THE SLIT LAMP A FEW DAYS AFTER THE SURGERY. THEY LOOKED LIKE COTTON FIBERS (HE EXCLUDED THAT IT IS COATING FROM THE CARTRIDGE). THIS HAPPENED TO 5 PTS WITHIN A TIME PERIOD OF 2 TO 3 WEEKS. PARTLY, THE FIBERS WERE STUCK WITHIN THE PARACENTESIS. THEY WERE REMOVED DURING A SECOND SURGERY. ONE PT SUFFERED FROM A FIBROUS REACTION BUT THE OUTCOME WAS GOOD. THE SURGEON STATED, IN ALL CASES THE OUTCOME OF THE SECOND SURGERY WAS GOOD AND THE VISUAL ACUITY WAS NOT AFFECTED. ADDITIONAL INFO REC'D 08/26/2008: THE SURGEON STATED THIS PT SUFFERED FROM AN INTRA-OCULAR INFECTION WITH INVOLVEMENT OF THE VITREOUS BODY. THE PT REQUIRED ANTERIOR CHAMBER INJECTION OF ANTIBIOTICS AND A TOPICAL PRESCRIPTION FOR EYE DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON-BELGIUM/S.A. ALCON-COUVREUR N.V. CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention