BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER XP

    MDR report key: 12155520 · Received July 12, 2021

    Report

    Report Number
    9615030-2021-00011
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    June 10, 2021
    Report Date
    June 14, 2021
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K993357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE POST-OP OUTCOME FOR THE PATIENT'S LEFT EYE (OS) SHOWS A VERY HIGH ERROR WITH PREDICTED RESIDUAL OUTCOME. THIS SEEMS TO BE LIKELY DUE TO THE KERATOMETRY (KER) MEASUREMENT DIFFERENCE WHEN COMPARED WITH RIGHT EYE (OD). THERE WAS PROBABLY A PROBLEM WITH THE KER MEASUREMENT FOR OS DUE TO CONTACT LENS USAGE CAUSING A SIGNIFICANT FLATTENING OF OS OR DRY EYES. THERE IS NO INDICATION OF ANY MALFUNCTION OF THE ZEISS DEVICE, WHICH COULD HAVE CONTRIBUTED TO THE POOR OUTCOMES. A NUMBER OF FACTORS NOT RELATED TO THE IOLMASTER MAY HAVE INFLUENCED THE SURGICAL OUTCOME. NOT ALL ARE CONTROLLED BY THE MANUFACTURER. THE USER MANUAL DESCRIBES IN DETAIL HOW TO PERFORM INTRAOCULAR LENS MEASUREMENTS AND CALCULATIONS AND CONTAINS WARNINGS ABOUT RELEVANT PARAMETERS.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THERE HAS BEEN AN INCORRECT SURGICAL RESULT AFTER USING THE IOLMASTER 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
    1051794 IOLMASTER XP BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention