BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER

    MDR report key: 6927515 · Received October 7, 2017

    Report

    Report Number
    9615030-2017-00021
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    August 16, 2017
    Report Date
    September 7, 2017
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K993357
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER REVIEWED THE PRE- AND POST-OP MEASUREMENT PRINTOUTS AS WELL AS THE IOL CALCULATION PRINTOUTS FROM THE DEVICE. THE CALCULATION OF THE IOL POWER PERFORMED BY THE DEVICE WAS CORRECT. HOWEVER, THE MEASUREMENT PRINTOUT DOES INDICATE IRREGULAR KERATOMETRY READINGS, THEREFORE IT IS RECOMMENDED THAT A REPEAT MEASUREMENT SHOULD BE TAKEN AS PRECAUTION. THE IOLMASTER USER MANUAL PROVIDES INFORMATION FOR SAFETY (000000-1322-734_DOKS_US_280709, PAGE 68): "WARNING: TO OBTAIN CONSISTENT RESULTS WE RECOMMEND CHECKING THE INDIVIDUAL KERATOMETER MEASUREMENTS AND CARRYING OUT FURTHER MEASUREMENTS IF NECESSARY." IN ADDITION, THE PATIENT'S MEDICAL HISTORY INDICATES AN EYE CONDITION (I.E. BLEPHARITIS) THAT MAY AFFECT THE CORNEA AND TEAR FILM INTEGRITY. FOR SUCH PATIENTS, CARE SHOULD BE TAKEN AND REPEATED MEASUREMENTS ARE RECOMMENDED OVER A LONGER PERIOD OF TIME (I.E. ONE MONTH) TO ENSURE STABILITY OF THE KERATOMETRY MEASUREMENTS. 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. AN ALCON SN6AT8 LENS WITH A POWER OF +28.0D WAS USED. THE OD POST-REFRACTIVE OUTCOME AFTER A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION DIFFERED -4.50 D FROM THE TARGET REFRACTION. THE HCP MADE A DECISION TO EXCHANGE THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707294 IOLMASTER BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other