BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK MK-2000, KERATOME

    MDR report key: 1190308 · Received October 6, 2008

    Report

    Report Number
    2936921-2008-00003
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    January 11, 2007
    Report Date
    October 3, 2008
    Manufacturer
    NIDEK CO. LTD
    Product Code
    HNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2008, NIDEK INC WAS NOTIFIED THAT PT INJURY HAD OCCURRED IN EARLY 2007. THIS NOTIFICATION CAME VIA THE INJURED PATIENTS ATTORNEY. NIDEK DID NOT RECEIVE ANY PRIOR NOTIFICATION OF ANY PT INJURY. ONCE WE RECEIVED, THE NOTIFICATION OF PT INJURY, WE BEGAN AN INVESTIGATION AND REQUESTED PT DATA. THE PHYSICIAN'S OFFICE WAS COOPERATIVE AND SENT THE INFO TO US IN A TIMELY MANNER. HOWEVER, THEY WERE UNABLE TO SUPPLY US WITH THE SERIAL NUMBER OF THE DEVICE USED DURING THIS PATIENTS SURGERY. THE SUMMARY OF THE PT DATA IS INCLUDED IN ATTACHMENT A. ACCORDING TO THE PT DATA, THIS PT HAD UNDERGONE LASIK TREATMENT IN 2002 BY ANOTHER PHYSICIAN, THERE ARE NO MEDICAL RECORDS TO SUPPORT THIS. THERE ARE NO RECORDS PAST(SEVEN MONTHS LATER). IT IS OUR UNDERSTANDING THAT THE PT THEN WENT TO ANOTHER PHYSICIAN FOR CARE. BASED ON THE PT DATA RECEIVED, IT IS DETERMINED THAT THE CAUSE OF THE PT INJURY IS INCONCLUSIVE. THE PT DATA REFERS TO PROBLEMS WITH DLK (DIFFUSE LAMELLAR KERATITIS), AND NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    PT HAS CLAIMED IN A LAW SUIT THAT HIS VISION HAS BEEN DAMAGED DUE TO THE LASIK SURGERY, HE HAD IN EARLY 2007. THE PT IS CLAIMING THAT THE DOCTOR WHO PERFORMED THE SURGERY DID NOT CHECK HIS EYES OR EXAMINE HIM BEFORE THE SURGERY. THE PT CLAIMS THAT THE DOCTOR WAS RELYING SOLELY ON THE EXAM DONE BY THE PERSON THE PT ORIGINALLY HAD SEEN. THE SURGERY WAS PERFORMED, AND THE PT CLAIMS TO HAVE HAD SEVERE PAIN AND BLEEDING IN THE LEFT EYE. THE PT STATES THAT THE PAIN DID NOT STOP AFTER THE SURGERY AND HE WAS STILL IN INTENSE PAIN AT THE 24 HOUR EXAM AND WAS TOLD, AT THIS TIME, THAT HE HAD "SANDS OF SAHARA" AKA DLK (DIFFUSE LAMELLAR KERATITIS). HE WAS GIVEN PRESCRIPTIONS AND THEN WAS SEEN BY THE DOCTOR WHO HAD PERFORMED THE SURGERY. THE PT WAS TOLD THAT THE "SANDS OF SAHARA" WOULD "WEAR OFF". AFTER SEVEN MONTHS, THE PT HAD AN ENHANCEMENT PROCEDURE (SIX MONTHS LATER). THE PT IS CLAIMING THAT AFTER THIS ENHANCEMENT PROCEDURE, HIS EYES WERE WORSE. THE PT IS NOW UNDER THE CARE OF ANOTHER DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIDEK MK-2000, KERATOME KERATOME, AC POWERED HNO NIDEK CO. LTD MK-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other