BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AL-SCAN

    MDR report key: 5823521 · Received July 26, 2016

    Report

    Report Number
    3002807715-2016-00029
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    February 3, 2016
    Report Date
    February 3, 2016
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HJB
    PMA / PMN Number
    K133132
    Removal / Correction Number
    2936921-7/01/2016-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN EVALUATED IN THIS CASE. HOWEVER, BASED ON THE INVESTIGATION INCLUDING INTERNAL TEST, THE NCO WAS ABLE TO DUPLICATE THE SIMILAR UNUSUAL AXIAL LENGTH AND WAVEFORMS BY ELECTRONIC DISCHARGE EXCEEDED THE CRITERIA. THE NCO CONSIDERED EXTERNAL ELECTROMAGNETIC DISTURBANCE IN ABNORMAL OPERATING CONDITIONS POSSIBLY MAY HAVE CAUSED TO AL-SCAN WHICH CONFORMS TO INTERNATIONAL STANDARDS FOR ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICE AND HAS BEEN VERIFIED TO OPERATE PROPERLY UNDER NORMAL OPERATING CONDITION. NO PATIENT INJURY OR ADVERSE EVENT WAS REPORTED IN THIS CASE. IN ORDER TO PREVENT THE INCIDENT IN CUSTOMER SITE IN THE UNITED STATES, NCO REQUESTED NIDEK INC. WHICH IS USA SUBSIDIARY OF NCO TO ALERT TO THIS SYMPTOM AND ALSO RECOMMENDED THAT THE SOFTWARE SHOULD BE UPGRADED WITH THE NEW VERSION. RECALL HAS BEEN INITIATED BY US UNDER RECALL REPORT NUMBER :2936921-7/01/2016-001-C.

    Description of Event or Problem · 1

    THE MANUFACTURER, NIDEK CO., LTD.(ABBREVIATED: NCO) RECEIVED FOLLOWING INFORMATION FROM (B)(6). THE AL-SCAN MEASUREMENT DATA OF AXIAL LENGTH WITH THE RIGHT EYE IS 20.31MM, AND THE LEFT EYE IS 20.36MM. THE WAVEFORM LOOKED FINE, BUT DUE TO THE FACT THAT THE AXIAL LENGTH SHOWED SHORTER THAN AVERAGE, FELT UNCOMFORTABLE WITH THE RESULT, AND USED ULTRASOUND A-MODE TO MEASURE THE AXIAL LENGTH AGAIN. AS A RESULT, BOTH AXIAL LENGTHS WERE 22MM. THE DOCTOR AND STAFF DISCUSSED ABOUT THE MEASURED RESULT AND DECIDED TO USE THE RESULT OF ULTRASOUND A-MODE MEASUREMENT. NO FURTHER MALFUNCTION HAS BEEN REPORTED EVER SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475124 AL-SCAN OPTICAL BIOMETER, HJB NIDEK CO., LTD. AL-SCAN

    Patients

    Seq Age Sex Outcome Treatment
    1