BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK MK-2000, KERATOME

    MDR report key: 1190309 · Received October 6, 2008

    Report

    Report Number
    2936921-2008-00004
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    January 12, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2008, NIDEK INC WAS NOTIFIED THAT THE PT INJURY HAD OCCURRED IN EARLY 2007. THIS NOTIFICATION CAME VIA THE INJURED PTS ATTY. NIDEK DID NOT RECEIVE ANY PRIOR NOTIFICATION OF ANY PT INJURY. ONCE WE REC'D 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 PTS SURGERY. THE SUMMARY OF THE PT DATA IS INCLUDED IN ATTACHMENT A. ACCORDING TO THE PT DATA, THERE ARE NO RECORDS PAST 10/04/2007. IT IS OUR UNDERSTANDING THAT THE PT THEN WENT TO ANOTHER PHYSICIAN FOR CARE. BASED ON THE PT DATA REC'D, IT IS DETERMINED THAT THE CAUSE OF THE PT INJURY IS INCONCLUSIVE. THE PT DATA REFERS TO PROBLEMS WITH HIS LEFT EYE FLAP AND SPK (SUPERFICIAL PUNCTATE KERATITIS), AND NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    PT HAD 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 DR WHO PERFORMED THE SURGERY DID NOT CHECK HIS EYES OR EXAMINE HIM BEFORE THE SURGERY. THE PT CLAIMS THAT HE STARTED EXPERIENCING PAIN IMMEDIATELY DURING THE SURGERY. PT CLAIMS THAT HIS ONE DAY POST OPERATIVE EXAM WAS NOT DONE BY THE PHYSICIAN WHO DID THE SURGERY, IT WAS DONE BY ANOTHER PERSON. PT STATED THAT HE IMMEDIATELY EXPERIENCED SIGNIFICANT PROBLEMS WITH THE SURGERY AFTER CARE. PT STATES THAT F/U CARE WAS CONDUCTED BY THIS SAME FACILITY UP UNTIL NINE MONTHS LATER. PT HAS BEEN SEEN BY ANOTHER PHYSICIAN AND WAS TOLD THAT HIS "EYES HAD EXPERIENCED SIGNIFICANT DAMAGE".

    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| R