BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 500

    MDR report key: 10865372 · Received November 18, 2020

    Report

    Report Number
    9615030-2020-00016
    Event Type
    Injury
    Date Received
    November 18, 2020
    Report Date
    October 21, 2020
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K122418
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THERE HAD BEEN AN INCORRECT SURGICAL RESULT AFTER USING THE IOLMASTER 500 FOR THE BIOMETRY MEASUREMENTS AND LENS POWER CALCULATIONS. THE HCP REPORTED THAT A LENS EXCHANGE WAS PERFORMED TO CORRECT THE PATIENT'S VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330017 IOLMASTER 500 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) 500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention