BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 700

    MDR report key: 6549879 · Received May 5, 2017

    Report

    Report Number
    9615030-2017-00007
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    April 6, 2017
    Report Date
    May 5, 2017
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K143275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A ZEISS FIELD SERVICE ENGINEER INSPECTED THE IOLMASTER 700 AND CONFIRMED THAT IT IS WORKING WITHIN MANUFACTURER SPECIFICATION. THE MANUFACTURER REVIEWED THE PRE- AND POST-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. A NUMBER OF FACTORS NOT RELATED TO THE IOLMASTER 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. THE RISK OF MEASURING ERRORS IS DESCRIBED IN DETAIL ON PAGE 7 OF THE USER MANUAL (000000-1932-169-GA-US-160715).

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THE FOLLOWING: THE OD POST-REFRACTIVE OUTCOME AFTER A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION DIFFERED -1.25 D FROM THE TARGET REFRACTION. THE ALCON ACRYSOF IQ MODEL SN60WF LENS WITH A POWER OF 10.0 D WAS USED. THE HCP MADE A DECISION TO EXCHANGE THE IOL. THE SAME LENS WITH A POWER OF 8.0 D WAS USED FOR THE RE-OP. ON ONE DAY POST-OP, THE PATIENT'S UCVA WAS 20/40 ON POD #1. THE IOLMASTER WAS USED FOR THE ORIGINAL BIOMETRY MEASUREMENTS AND IOL CALCULATIONS AS WELL AS FOR THE SECOND BIOMETRY MEASUREMENTS AND CALCULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330201 IOLMASTER 700 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other