BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 700

    MDR report key: 6709025 · Received July 12, 2017

    Report

    Report Number
    9615030-2017-00013
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    June 13, 2017
    Report Date
    August 18, 2017
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K143275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER PERFORMED AN IN-HOUSE INVESTIGATION OF THE IOLMASTER 700. THE DEVICE WAS VERIFIED AS WORKING WITHIN SPECIFICATION. INSPECTION OF THE PATIENT'S PRE-OP MEASUREMENT DATA SHOWED WEAK RETINA SIGNALS AND LONG AXIAL LENGTH (AL) MEASUREMENT FOR BOTH EYES. A WARNING FOR LONG EYE LENGTH IS DISPLAYED. AN ADDITIONAL SIGNAL (ARTIFACT) BEHIND THE RETINA WAS FOUND. FURTHER EXAMINATION OF THE DEVICE REVEALED DISTINCT FINGERPRINTS ON THE OUTER SIDE OF THE COVER GLASS. THESE FINGERPRINTS ARE THE ROOT CAUSE FOR THE ARTIFACT IN THE OCT SCANS. THE DEVICE ALGORITHMS IDENTIFIED THE ARTIFACT AS THE RETINA STRUCTURE. THIS GAVE WRONG AL MEASUREMENT WITH VALUES AROUND 33-37MM. THE USER MANUAL (000000-1932-169-DOKS-GB-150814) DESCRIBES IN DETAIL HOW TO EVALUATE MEASUREMENT QUALITY AND CONTAINS WARNINGS ABOUT RELEVANT PARAMETERS. PROPER CLEANING OF OPTICAL SURFACES IS DESCRIBED ON PAGE 46 OF THE MANUAL. DESCRIPTION OF FURTHER UPDATES: ENTERED ACTUAL DATE FOR THIS MDR FOLLOW-UP. UPDATED DEVICE AVAILABILITY TO INCLUDE DATE RETURNED TO MANUFACTURER. MFR SITE: (NAME & ADDRESS): UPDATED CONTACT OFFICE NAME, ADDRESS, PHONE NUMBERS. ADVERSE EVENT: UPDATED FROM "INITIAL" TO "FOLLOW-UP #: 1". IF FOLLOW-UP, WHAT TYPE?: ENTERED "ADDITIONAL INFORMATION". ADDED MANUFACTURER NARRATIVE AND DESCRIPTION OF FURTHER UPDATES.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THE FOLLOWING: THE POST-REFRACTIVE OUTCOME AFTER A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION DIFFERED +15.5 DIOPTERS FROM THE TARGET REFRACTION. THE HCP INFORMED THAT AN IOL EXCHANGE IS PLANNED. THE IOL MASTER WAS USED FOR THE ORIGINAL BIOMETRY MEASUREMENTS AND IOL CALCULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486028 IOLMASTER 700 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention