BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALADDIN HW3.0

    MDR report key: 17299756 · Received July 11, 2023

    Report

    Report Number
    2242863-2023-00001
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    April 17, 2023
    Report Date
    March 27, 2025
    Manufacturer
    VISIA IMAGING S.R.L.
    Product Code
    HJO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT HAD AN INTRAOCULAR LENS (IOL) IMPLANTED INTO THEIR RIGHT EYE THAT RESULTED IN A VISION OUTCOME 1.5 DIOPTERS OFF FROM THE INTENDED RESULT. THE ALADDIN PRODUCT, AN OPHTHALMIC DEVICE INTENDED TO OBTAIN BIOMETRIC MEASUREMENTS, WAS USED PRIOR TO SURGERY TO DETERMINE WHAT IOL TO IMPLANT. THE DEVICE WAS SET TO A TARGET REFRACTION OF -1.5 DIOPTERS, BUT THE PATIENT OUTCOME POST-SURGERY SHOWED 0 DIOPTER REFRACTION. ALTHOUGH THIS END RESULT DOES PROVIDE BETTER VISION FOR THE PATIENT THAN IF THEY WOULD HAVE RECEIVED IOL WITH A -1.5 DIOPTER ADJUSTMENT, AND THEREFORE NO HARM OCCURRED AND ADDITIONAL SURGERY IS NOT NEEDED, IT REMAINS THAT THE ACTUAL OUTCOME IS DIFFERENT FROM THE INTENDED OUTCOME. IT SHOULD BE NOTED THAT THERE IS A DISCLAIMER IN BOTH THE DEVICE USER INTERFACE WHEN USING THE RELATED TOOL AND THE USER MANUAL (FIGURE 43) STATING THAT THE IOL CALCULATOR TOOL IS TO BE USED CONCURRENTLY WITH A COMPREHENSIVE OPHTHALMIC EXAMINATION, SPECIFIC DIAGNOSTIC TESTS, AND MEASUREMENTS FOR THE PATIENT RECEIVING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193708 ALADDIN HW3.0 BIOMICROSCOPE HJO VISIA IMAGING S.R.L. 1240212US

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male