BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK MK-2000, KERATOME

    MDR report key: 1190321 · Received October 6, 2008

    Report

    Report Number
    2936921-2008-00005
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    March 27, 2008
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09/08/2008, NIDEK INC WAS NOTIFIED THAT THE PATIENT INJURY HAD OCCURRED ON APPROX FOUR MONTHS EARLIER. THIS NOTIFICATION CAME VIA THE INJURED PATIENTS ATTORNEY. NIDEK DID NOT RECEIVE ANY PRIOR NOTIFICATION OF ANY PATIENT INJURY. ONCE WE RECEIVED THE NOTIFICATION OF PATIENT INJURY, WE BEGAN AN INVESTIGATION PROCESS AND REQUESTED PATIENT DATA. THE PHYSICIANS OFFICE WAS COOPERATIVE AND SENT THE INFORMATION 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 PATIENT DATA IS INCLUDED IN ATTACHMENT A. ACCORDING TO THE PATIENT DATA, THERE ARE NO RECORDS PAST 04/17/2008. IT IS OUR UNDERSTANDING THAT THE PATIENT THEN WENT TO ANOTHER PHYSICIAN FOR CARE. BASED ON THE PATIENT DATA RECEIVED, IT IS DETERMINED THAT THE CAUSE OF THE PATIENT INJURY IS INCONCLUSIVE. THE PATIENT DATA REFERS TO PROBLEMS WITH DLK (DIFUSE LAMELLAR KERATITIS) IN BOTH EYES, AND NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    PATIENT HAS CLAIMED, IN A LAW SUIT, THAT HIS VISION HAS BEEN DAMAGED DUE TO THE LASIK SURGERY PROCEDURE IN 2008. THE PATIENT IS CLAIMING THAT THE OPTOMETRIST WHO CONDUCTED THE EYE EXAM, DID NOT PERFORM ALL THE NECESSARY TESTS TO PROPERLY DETERMINE IF HE WAS A CANDIDATE FOR LASIK SURGERY. THE PATIENT CLAIMS THAT IMMEDIATELY AFTER THE SURGICAL PROCEDURE, HE STARTED EXPERIENCING PAIN IN HIS EYES. THE PATIENT CLAIMS HE CONTINUED TO EXPERIENCE SIGNIFICANT PROBLEMS WITH THE SURGERY AND THE AFTER CARE. THE PATIENT CONSULTED ANOTHER PHYSICIAN WHO TOLD HIM THAT HE WOULD LIKELY NEED ADDITIONAL SURGERY OR USE PERMANENT RIGID GAS PERMEABLE (HARD) CONTACT LENSES IN AN ATTEMPT TO REHABILITATE HIS VISION. THIS PHYSICIAN STATED TO THE PATIENT THAT HE HAD DEVELOPED DLK (DIFFUSE LAMELLAR KERATITIS) - RELATED CORNEAL INTERFACE OPACITIES IN BOTH EYES.

    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