BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IOLMASTER 700

    MDR report key: 11060695 · Received December 22, 2020

    Report

    Report Number
    9615030-2020-00024
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    October 15, 2020
    Report Date
    November 24, 2020
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K143275
    Removal / Correction Number
    9615030-12-16-2020-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE IOLMASTER 700 IS ERRONEOUSLY SELECTING ANOTHER PATIENT ON MODALITY WORKLIST (MWL) RATHER THAN THE HIGHLIGHTED PATIENT. THERE IS NO INJURY REPORTED TO THE PATIENT, USER, OR THIRD PARTY DUE TO THE REPORTED CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524031 IOLMASTER 700 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) 700 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1