BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK EC-5000 EXCIMER LASER SYSTEM

    MDR report key: 3415463 · Received October 11, 2013

    Report

    Report Number
    3002807715-2013-00009
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    February 21, 2009
    Report Date
    October 10, 2013
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LZS
    PMA / PMN Number
    P970053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION BY NIDEK INC. CONCLUDES THAT "WE INVESTIGATED IN RESPONSE TO FDA, BUT THE REPORTER REFUSED TO PROVIDE ANY INFORMATION ON THE SURGICAL FACILITY AND SURGERY DETAILS. THEREFORE, THE DEVICE CANNOT BE IDENTIFIED AND FURTHER INVESTIGATION IS NOT POSSIBLE DUE TO LACK OF INFORMATION." NIDEK CO., LTD. ASKED NIDEK INC. FOR ADDITIONAL INVESTIGATION. SINCE NIDEK CO., LTD ALSO COULD NOT HAVE FURTHER INFORMATION TO PERFORM ADDITIONAL INVESTIGATION AS A MANUFACTURER, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE INJURY. IF FURTHER INFORMATION IS RECEIVED, WE WILL SUBMIT A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    NIDEK RECEIVED MAUDE EVENT REPORT (B)(4) ON (B)(6) 2012. THE FOLLOWING INFORMATION IS PER THE MAUDE EVENT REPORT. LASIK PROCEDURE PERFORMED (B)(6) 2009 RIGHT EYE AND PRK PROCEDURE PERFORMED (B)(6) 2009 LEFT EYE. CORNEAL FLAP CREATED IN THE RIGHT EYE WITH A MICROKERATOME OF UNKNOWN MANUFACTURER AND CUT INCORRECTLY. FLAP TOOK 15 MINUTES TO PLACE BACK DOWN ON THE CORNEAL BED. DOCTOR ADHERED THE CORNEAL FLAP USING THE LASER AND PLACED A BANDAGE CONTACT LENS ON THE RIGHT EYE. DOCTOR DECIDED TO PERFORM PRK ON LEFT EYE. EPITHELIUM REMOVAL OF THE LEFT EYE WAS PAINFUL AND WAS PERFORMED WITHOUT A LOCAL ANESTHESIA BECAUSE THE DROPS ADMINISTERED PREVIOUSLY HAD WORN OFF. BANDAGE CONTACT LENS PLACED IN THE LEFT EYE AFTER THE LASER TREATMENT. PT CONTACTED DOCTOR THE EVENING OF THE SURGERY DAY TO REPORT PAIN, UNCONTROLLABLE TEARING AND BAD VISION AND WAS TOLD IT'S NORMAL. SEEN IN 2009 FOR FOLLOW UP AND WAS TOLD THERE HAD BEEN A PROBLEM CUTTING THE FLAP AND THEY WERE GOING TO MONITOR THE RIGHT EYE CAREFULLY. NIDEK CO., LTD. PREPARED THE CUSTOMER COMPLAINT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522349 NIDEK EC-5000 EXCIMER LASER SYSTEM NONE LZS NIDEK CO., LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention