BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 700

    MDR report key: 19735265 · Received July 12, 2024

    Report

    Report Number
    9615030-2024-00015
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 12, 2024
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    UDI-DI
    04049471092080
    PMA / PMN Number
    K173771
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOST POSSIBLE ROOT CAUSE IS A USER ERROR. THE ISSUE WAS NOT RELATED TO THE EQUIPMENT BUT A MIX UP ON THE RECORDS AT THE CLINIC. THERE IS NO INDICATION OF ANY MALFUNCTION OF THE ZEISS DEVICE THAT COULD HAVE CONTRIBUTED TO THE UNEXPECTED SURGICAL OUTCOME. THE DEVICE WORKED WITHIN ZEISS SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DOCTOR PERFORMED SURGERY WITH CLEAR LENS AND THE DEVIATION IN SURGERY RESULT WAS +1.5 DIOPTER. THE DOCTOR HAD TO EXCHANGE THE LENS TO CORRECT PATIENT'S VISION. THE DOCTOR COMMUNICATED THAT THE TEST EYE CHECK PASSED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902334 IOLMASTER 700 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) 700 04049471092080

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention