BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED SYSTEM

    MDR report key: 3396636 · Received September 17, 2013

    Report

    Report Number
    2028159-2013-01815
    Event Type
    Malfunction
    Date Received
    September 17, 2013
    Report Date
    August 23, 2013
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    HQC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    J ACATARACT REFRACT SURG 2013; 39:1008-1010. NO SAMPLES WERE RETURNED FOR EVAL FOR "METAL PARTICLES". NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. BASED ON THE REVIEW, THE LITERATURE CONCLUSIONS MAY NOT BE CORRECT. THE PHACO WRENCH APPEARS TO HAVE BEEN USED BEYOND ITS USEFUL LIFE BASED ON THE ARTICLE PHOTO AND THE TORQUE FORCE BEING APPLIED MAY ALSO HAVE BEEN EXCESSIVE RESULTING IN THE JAGGED SQUARE EDGES CONDITION OF THIS PARTICULAR WRENCH. THE VISUAL CONDITION OF THIS PARTICULAR WRENCH IS POOR AND SHOULD NOT HAVE BEEN USED. THE WRENCH SHOULD BE EXAMINED PRIOR TO ITS USE. THE LITERATURE STATES THAT THE PHACO NEEDLES ARE BEING USED AN AVERAGE OF 10 TIMES. PHACO TIPS ARE DISPOSABLE DEVICES AND ARE NOT RECOMMENDED FOR REUSE. EACH REUSE OF A PHACO TIP INCREASES THE PROBABILITY THAT PARTICULATE WILL BE SHED FROM THE TIP. THE LITERATURE STATES THE PARTICULATE COMPOSITION WAS CARBON, MAGNESIUM, AND SILICON, AND THIS MATCHES THE WRENCH HAVING A COMPOSITION OF CARBON, MAGNESIUM, SILICON, AND TITANIUM. A REUSABLE WRENCH METAL DOES NOT CONTAIN ANY TITANIUM AND HAS ONLY TRACE AMOUNTS OF CARBON, MAGNESIUM AND SILICON. THE ARTICLE DOES NOT SPECIFY THE PERCENTAGE OF COMPOSITION TO ASSIST IN BETTER CLARIFYING THE SOURCE OF THE PARTICULATE. BASED ON THE PARTICULATE ANALYSIS AND THE COMPOSITION OF THE THREE INSTRUMENTS NOTED IN THIS ARTICLE, ONE COULD CONCLUDE THAT THE METAL PARTICULATE EXTRACTED COULD HAVE COME FROM THE PHACO TIP, WRENCH, CHAMBER MAINTAINER, OR SOME OTHER SOURCE NOT MENTIONED IN THIS LITERATURE. THE ROOT CAUSE FOR "METAL PARTICLES" CANNOT BE DETERMINED FROM THIS EVAL. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT HE WAS AWARE OF A PUBLISHED JOURNAL ARTICLE REGARDING THE DETERMINATION OF THE NATURE AND ORIGIN OF METALLIC PARTICLES APPEARING ON THE IRIS FOLLOWING PHACOEMULSIFICATION PROCEDURES. THE SURGEON WAS CONCERNED BECAUSE HE WAS AFRAID THAT THIS ARTICLE WOULD CAUSE "PANIC" IN MEDICAL COMMUNITY IN REGARDS TO THE USE OF THE PHACO NEEDLE TIGHTENING WRENCHES. THE SURGEON INDICATED THAT THE PHACO NEEDLE TIGHTENING WRENCHES HAVE PREVIOUSLY BEEN KNOWN TO CAUSE METAL PARTICLES TO ENTER INTO THE EYE. THE SURGEON ALSO INDICATED THAT THIS ARTICLE CITED, "SERIOUS METHODOLOGICAL FLAWS IN THE RESEARCH PUBLISHED, AS THERE SEEMS TO BE A PRECONCEIVED NOTION THAT THE WRENCH IS A CAUSE OF METAL IN THE EYE. OTHERWISE THERE IS NO REASON TO SEND IT FOR AN EXPENSIVE SCANNING ELECTRON MICROSCOPY ANALYSIS AT THE OUTSET, WITHOUT A PLAUSIBLE HYPOTHESIS." ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467251 UNSPECIFIED SYSTEM UNSPECIFIED SYSTEM HQC ALCON MANUFACTURING, LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK