BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 500

    MDR report key: 6324126 · Received February 10, 2017

    Report

    Report Number
    9615030-2017-00002
    Event Type
    Injury
    Date Received
    February 10, 2017
    Date of Event
    January 5, 2017
    Report Date
    August 3, 2017
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K122418
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER REVIEWED THE DATA LOGS AND THE MEASUREMENT AND IOL CALCULATION PRINTOUTS FROM THE IOLMASTER. NO ABNORMALITIES WERE FOUND. THE MANUFACTURER PERFORMED AN IN-HOUSE INVESTIGATION OF THE DEVICE. THE RIGHT AND LEFT TEST EYE CALIBRATION VALUES WERE FOUND TO BE OUT OF TOLERANCE. HOWEVER, THE SLIGHT DEVIATION OF 0.14MM IN ANTERIOR CHAMBER DEPTH MEASUREMENT CANNOT EXPLAIN THE SURGICAL OUTCOME, AS THE DEVIATION WOULD ONLY LEAD TO A DIFFERENCE OF LESS THAN 0.5D IN OUTCOME. A NUMBER OF FACTORS NOT RELATED TO THE IOLMASTER MAY HAVE INFLUENCED THE SURGICAL OUTCOME. THE RISK OF MEASURING ERRORS IS DESCRIBED IN DETAIL ON PAGE 7 OF THE USER MANUAL (000000-1692-983-DOKS-US-170413). ON PAGES 26-30 OF THE MANUAL, THE USER IS GIVEN DIRECTIONS FOR CHECKING THE MEASUREMENT FUNCTIONS OF THE DEVICE PRIOR TO EACH USE. (B)(4).

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL REPORTED THE FOLLOWING: THE OS POST REFRACTIVE OUTCOME AFTER A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION DIFFERED +2.25 DIOPTERS FROM THE TARGET REFRACTION. THE ALCON ACRYSOF (B)(4) LENS WAS USED. THE HEALTHCARE PROFESSIONAL INFORMED THAT A RE-OP IS PLANNED WHERE AN ADDITIONAL PIGGYBACK LENS WILL BE IMPLANTED. THE IOLMASTER WAS USED FOR THE ORIGINAL BIOMETRY MEASUREMENTS AND IOL CALCULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107147 IOLMASTER 500 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other