BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 500

    MDR report key: 3998847 · Received July 17, 2014

    Report

    Report Number
    9615010-2014-00012
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 3, 2014
    Report Date
    July 17, 2014
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    HJO
    PMA / PMN Number
    K122418
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) PERFORMED AN ON-SITE EXAMINATION OF THE IOLMASTER 500. ALL PARAMETERS THAT INFLUENCE MEASUREMENT WERE WITHIN SPECIFICATION. TWO PARAMETERS WHICH DO NOT INFLUENCE THESE MEASUREMENTS WERE OUT OF SPECIFICATION AND ADJUSTED TO WITHIN SPECIFICATION. THE MANUFACTURER REVIEWED THE IOL CALCULATION REPORT AND FOUND THE CALCULATION PERFORMED BY THE IOLMASTER 500 WERE CORRECT. WHEN THE IOLMASTER 500 USED BY A NUMBER OF DIFFERENT SURGEONS IT IS RECOMMENDED TO CREATE SURGEON SPECIFIC RECORDS IN THE LENS MANAGER. THE USE OF THE LENS MANAGER IS DESCRIBED IN THE SOFTWARE USE MANUAL ON PAGE 21 AND 22. THE SITE REPORTED THAT THEY HAVE IMPLEMENTED A CROSS-CHECKING PROTOCOL IN THEIR WORKFLOW TO SAFEGUARD AGAINST RECURRENCE OF THE REPORTED USER ERROR PROBLEM. THE SITE CONTACT IS THE SAME AS THE INITIAL REPORTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A TECHNICIAN HAD SELECTED THE WRONG SURGEON'S NAME IN THE IOL CALCULATION SCREEN IN THE IOLMASTER 500. THE OPERATING SURGEON DID NOT NOTICE THAT THE PRINTOUT REFLECTED ANOTHER SURGEON'S AC LENS IN HIS PREFERRED LENS COLUMN. AS A RESULT, THE OPERATING SURGEON CHOSE THE WRONG LENS AND LENS POWER FOR HIS PATIENT. THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY: 20/125 BEST CORRECTED. THE PATIENT'S POST-OPERATIVE VISUAL ACUITY: 20/20 BEST CORRECTED AND 20/125 UNCORRECTED. THE PATIENT'S STABLE POST-OPERATIVE REFRACTION: +3.75 DS. THE DIFFERENCE FROM TARGET REFRACTION: +3.75 DS. THE OPERATING SURGEON PERFORMED A FOLLOW-UP SURGERY TO EXPLANT THE UNINTENDED IOL AND IMPLANT THE INTENDED IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418937 IOLMASTER 500 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG IOLMASTER 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other