BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER

    MDR report key: 5478523 · Received March 3, 2016

    Report

    Report Number
    9615030-2016-00002
    Event Type
    Injury
    Date Received
    March 3, 2016
    Report Date
    March 3, 2016
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K993357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED AN ON-SITE EXAMINATION OF THE IOLMASTER. NO DEVIATION IN THE READINGS FOR AXIAL LENGTH, KERATOMETRY, ANTERIOR CHAMBER DEPTH, OR WHITE-TO-WHITE WERE FOUND. THE HEALTHCARE PROVIDER MADE A DECISION TO PROCEED WITH THE ORIGINAL IMPLANTATION ALTHOUGH THE MEASUREMENT PRINTOUT SHOWED DIFFERENT OD AND OS K-VALUES AND INCLUDED THE REMARK: "THE KER- READINGS SHOULD BE CHECKED FOR PLAUSIBILITY, AS THERE MIGHT BE PATHOLOGICAL CHANGES." THE QUALITY OF THE K-MEASUREMENT HIGHLY DEPENDS UPON THE QUALITY OF THE TEAR FILM, CORRECT FIXATION AND WIDE OPEN EYES.

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL REPORTED THE FOLLOWING: THE POST REFRACTIVE OUTCOME FOR AN EYE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION WAS OD -2.75 DIOPTERS. THE HEALTHCARE PROFESSIONAL MADE A DECISION TO EXCHANGE THE IOL. THE IOLMASTER WAS USED FOR THE ORIGINAL BIOMETRY MEASUREMENTS AND IOL CALCULATIONS AS WELL AS FOR THE SECOND BIOMETRY MEASUREMENTS AND CALCULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134133 IOLMASTER BIOMICROSCOPE, SLIT-LAMP, AC-POWERED, PRODUCT CODE: HJO HJO CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other