BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER

    MDR report key: 6950226 · Received October 13, 2017

    Report

    Report Number
    9615030-2017-00022
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    August 11, 2017
    Report Date
    September 14, 2017
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K993357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECIDED NOT TO REPAIR THE INSTRUMENT AT THIS TIME. THEREFORE, REPLACEMENT OF THE IOLMASTER HEAD AS INDICATED IN THE INITIAL REPORT WAS NOT POSSIBLE. UPDATED FROM "14-SEP-2017" TO "18-OCT-2017" FOR FOLLOW UP. UPDATED FROM "INITIAL" TO "FOLLOW-UP #: 1". ENTERED "ADDITIONAL INFORMATION". ADDED DESCRIPTION OF FURTHER UPDATES.

    Additional Manufacturer Narrative · 1

    A NUMBER OF FACTORS NOT RELATED TO THE LOLMASTER MAY HAVE INFLUENCED THE SURGICAL OUTCOME. THE QUALITY OF KERATOMETRY MEASUREMENTS IS HIGHLY DEPENDENT ON STABLE TEAR FILM, CORRECT FIXATION, AND WIDE OPEN EYES. 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

    THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THE FOLLOWING: THE IOLMASTER WAS USED FOR THE PATIENT'S BIOMETRY MEASUREMENTS. THE ALCON SA60AT LENS WITH A POWER OF +17.0 DIOPTER WAS USED. THE OS POST-REFRACTIVE OUTCOME AFTER A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION DIFFERED -6.00 DIOPTER FROM THE TARGET REFRACTION. THE HCP MADE A DECISION TO EXCHANGE THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727263 IOLMASTER BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) XP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other