BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPCON ALADDIN BIOMETER

    MDR report key: 9368888 · Received November 22, 2019

    Report

    Report Number
    MW5091263
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Report Date
    November 21, 2019
    Manufacturer
    TOPCON MEDICAL SYSTEM, INC.
    Product Code
    HJO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TOPCON ALADDIN BIOMETER IS RANDOMLY CHANGING THE LENS CONSTANTS ON PRINT-OUT WITHOUT USER INPUT. THIS IS CAUSING THE WRONG CALCULATION TO BE DISPLAYED. I CAUGHT THE ERROR AND CONTACTED TOPCON AND LEFT A VM BUT THEY NEVER RETURNED MY MESSAGE. IF I HAD NOT NOTICED THE INCORRECT LENS CONSTANT, PT COULD HAVE ENDED UP WITH INCORRECT LENS IMPLANT POWER IN THE EYE. WOULD LIKE TO MAKE SURE THIS SERIOUS GLITCH DOESN'T CAUSE INJURY TO OTHER PTS OF OTHER OPHTHALMOLOGISTS WHO MAY NOT BE AWARE OF THIS PROBLEM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159762 TOPCON ALADDIN BIOMETER BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO TOPCON MEDICAL SYSTEM, INC. ALADDIN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other