BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 4174600 · Received August 8, 2014

    Report

    Report Number
    2028159-2014-01463
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ALCON -IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE FACILITY DID NOT REQUEST SERVICE. NO ADDITIONAL INFO WAS OBTAINED IN RELATION TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. FOR THIS PHACO HANDPIECE (HP), THE SERIAL NUMBER (S/N) WA SNOT PROVIDED AND COULD NOT BE DETERMINED BASED ON THE INFO PROVIDED. THEREFORE, A COMPLAINT SERIAL NUMBER (S/N) REVIEW COULD NOT BE PERFORMED. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY, DURING THE IRRIGATION AND AT THE END, THE SURGEON NOTED NUMEROUS BLUE/BLACK STRANDS LIKE THREADS IN THE ANTERIOR CHAMBER OF PTS RIGHT EYE (OD). THE MORE SHE ATTEMPTED TO ASPIRATE THEM, MORE ENTERED ANTERIOR CHAMBER. MOST OF THEM WERE REMOVED USING BSS. THE SURGEON STOPPED OPERATING AND REQUESTED A DIFFERENT BATCH OF BSS. THE SURGEON'S FIRST ASSUMPTION WAS THAT THE BSS WAS THE SOURCE, BUT THEN SHE ASPIRATED WITH THE HANDPIECE-(I/A) USED AND IT DID SHOW WHITE STRANDS IN THE FLUID. THE SURGEON DID NOT KNOW WHICH WAS THE SOURCE OF THE STRANDS. THE SURGERY WAS COMPLETED. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470638 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON -IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR OZIL TORSIONAL PHACO HANDPIECE| BSS