BEUDAMED
    FDA Adverse Event Other Summary report: N

    MORIA LSK ONE

    MDR report key: 1532048 · Received November 16, 2009

    Report

    Report Number
    MW5013571
    Event Type
    Other
    Date Received
    November 16, 2009
    Date of Event
    September 1, 2008
    Report Date
    November 6, 2009
    Manufacturer
    MORIA
    Product Code
    HMY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PARACENTRAL/CENTRAL TOXIC KERATOPATHY. I HAVE PERSONALLY EXAMINED 3 PTS, AND AM AWARE OF ABOUT 3 MORE. I HAVE SEEN THESE PTS IN CONSULTATION, AFTER THEY WERE REFERRED TO ME BY THEIR LASIK SURGEON. ALL PTS UNDERWENT UNCOMPLICATED LASIK SURGERY USING THE MORIA LSK ONE DISPOSABLE MICROKERATOME AND SUBSEQUENTLY DEVELOPED A SEVERE CENTRAL/PARACENTRAL "TOXIC KERATOPATHY", ASSOCIATED WITH SEVERE, MEDICALLY RECALCITRANT DIFFUSE LAMELLAR KERATITIS WHICH, IN SOME CASES WAS TREATED WITH FLAP LIFTING AND IRRIGATION. MOST CASES WERE BILATERAL, YET ASYMMETRIC. MOST CASES RESULTED IN FLAP THINNING, WITH SCAR TISSUE, AND IRREGULAR ASTIGMATISM, RESULTING IN PERMANENT VISUAL LOSS. MY UNDERSTANDING IS THAT THIS MATTER HAS BEEN BROUGHT TO THE ATTENTION OF THE MANUFACTURER. NO PUBLIC ANNOUNCEMENTS HAVE BEEN MADE, IN SPITE OF THE FACT THAT THIS HAS OCCURRED IN MULTIPLE DISPARATE LOCATIONS. APPARENTLY THE PROBLEM WAS FINALLY RESOLVED BY RINSING THE TURBINES IN ALCOHOL OR SOMETHING TO THAT EFFECT. THE SURGEON WHO REFERRED THE CASES TO ME HAS CHOSEN NOT TO REPORT THESE CASES FORMALLY TO THE FDA, SO I DO NOT HAVE ANY MORE SPECIFIC INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORIA LSK ONE DISPOSABLE MICROKERATOME HMY MORIA

    Patients

    Seq Age Sex Outcome Treatment
    1