BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 700

    MDR report key: 6888247 · Received September 22, 2017

    Report

    Report Number
    9615030-2017-00020
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    August 23, 2017
    Report Date
    August 23, 2017
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K143275
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 PROVIDED SERVICE PROTOCOLS, THE PRE- AND POST-OP MEASUREMENT AND IOL CALCULATION PRINTOUTS FROM THE DEVICE. THESE PRINTOUTS DO NOT SHOW ANY ABNORMALITY. THE CALCULATION OF THE IOL POWER PERFORMED BY THE DEVICE WAS CORRECT. THE DATA PROVIDED SHOW TWO WARNINGS/CAUTION INDICATORS: SHORT EYE AND BORDERLINE SIGNAL QUALITY INDICATOR. AXIAL LENGTH SHOULD BE TAKEN INTO CONSIDERATION FOR IOL CALCULATION USING SUITABLE FORMULAE. IN ADDITION, ACCORDING TO THE USER MANUAL, WHEN ONE OR MORE YELLOW SIGNAL QUALITY INDICATORS APPEAR, REPEAT MEASUREMENTS ARE RECOMMENDED PRIOR TO A FINAL CLINICAL DETERMINATION. A NUMBER OF FACTORS NOT RELATED TO THE LOLMASTER MAY HAVE INFLUENCED THE SURGICAL OUTCOME. 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-DOKS-US-070815).

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THE FOLLOWING:THE IOLMASTER WAS USED FOR THE ORIGINAL BIOMETRY MEASUREMENTS. THE OS POST-REFRACTIVE OUTCOME AFTER A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION DIFFERED +1.00 D FROM THE TARGET REFRACTION. THE BAUSCH AND LOMB CRYSTALENS AO LENS WITH A POWER OF +28.00D WAS USED. THE HCP MADE A DECISION TO EXCHANGE THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665420 IOLMASTER 700 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other