BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IOLMASTER 700

    MDR report key: 11041501 · Received December 18, 2020

    Report

    Report Number
    9615030-2020-00022
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Date of Event
    October 26, 2020
    Report Date
    November 26, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    * G6: FOLLOW UP * H2: CORRECTION * H6: HEALTH EFFECT CLINICAL CODE CORRECTED TO 4582; HEALTH EFFECT IMPACT CODE CORRECTED TO 2199; INVESTIGATION FINDINGS CORRECTED TO 104; INVESTIGATION CONCLUSIONS CORRECTED TO 4301.

    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 INFORMATION ABOUT ANY NEGATIVE IMPACT TO THE PATIENT, USER, OR THIRD PARTY DUE TO THE REPORTED CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507347 IOLMASTER 700 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) 700

    Patients

    Seq Age Sex Outcome Treatment
    1