BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 500

    MDR report key: 6591807 · Received May 25, 2017

    Report

    Report Number
    9615030-2017-00008
    Event Type
    Injury
    Date Received
    May 25, 2017
    Date of Event
    March 21, 2017
    Report Date
    May 25, 2017
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K122418
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A ZEISS FIELD SERVICE ENGINEER INSPECTED THE IOLMASTER 500 AND CONFIRMED THAT IT IS WORKING WITHIN MANUFACTURER SPECIFICATION. THE MANUFACTURER EVALUATED PRE-OP MEASUREMENT AND IOL CALCULATION PRINTOUTS FROM THE DEVICE. THESE PRINTOUTS DO NOT SHOW ANY ABNORMALITY. THE DEVICE MEASURES WITHIN SPECIFICATION. THE CALCULATION OF THE IOL POWER PERFORMED BY THE DEVICE WAS CORRECT. DURING THE INVESTIGATION, THE CUSTOMER INFORMED THAT THE PATIENT REMOVED CONTACT LENSES THE SAME DAY OF MEASUREMENT AND THE USE OF LUBRICATING DROPS WAS REQUIRED. A NUMBER OF FACTORS NOT RELATED TO THE IOLMASTER MAY HAVE INFLUENCED THE SURGICAL OUTCOME. THE RISK OF MEASURING ERRORS, INCLUDING CONTACT LENS USE AND TEAR FILM, IS DESCRIBED IN DETAIL IN THE USER MANUAL ON PAGE 7 (000000-1692-983-DOKS-US-170413). THE QUALITY OF K-MEASUREMENT HIGHLY DEPENDS 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 HEALTH CARE PROFESSIONAL (HCP) REPORTED THE FOLLOWING: THE OS POST-REFRACTIVE OUTCOME AFTER A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION DIFFERED FROM THE TARGET REFRACTION. THE ALCON ACRYSOF IQ MODEL SN60WF LENS WAS USED. THE HCP DID NOT INFORM ABOUT THE LENS POWER USED OR THE POST-OP REFRACTION. THE HCP MADE A DECISION TO EXCHANGE THE IOL. THE SAME LENS WITH A POWER OF 16.5 D WAS USED FOR THE RE-OP. THE IOLMASTER WAS USED FOR THE BIOMETRY MEASUREMENTS AND IOL CALCULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371304 IOLMASTER 500 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other