BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 500

    MDR report key: 3040143 · Received April 3, 2013

    Report

    Report Number
    9615030-2013-00004
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    March 4, 2013
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA SITE)
    Product Code
    HJO
    PMA / PMN Number
    K101182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED AN ON-SITE INSPECTION OF THE IOLMASTER 500. THE INSTRUMENT WAS FOUND TO BE WORKING WITHIN SPECIFICATIONS FOR THOSE PARAMETERS THAT AFFECT THE IOL CALCULATION, INCLUDING AXIAL LENGTH, KERATOMETRY, WHITE-TO-WHITE AND ANTERIOR CHAMBER DEPTH MEASUREMENTS. THE INSTRUMENT WAS FOUND TO BE OUT OF SPECIFICATION FOR SLED SPEED AND AXIAL LENGTH END LIMITS. THE MEASUREMENT HEAD WAS REPLACED TO ADDRESS THE END LIMITS AND THE INSTRUMENT WAS DETERMINED TO BE WORKING WITHIN SPECIFICATION. THE MANUFACTURER'S EVALUATION OF THE ROOT CAUSE IS ONGOING. SITE CONTACT: SAME AS INITIAL REPORTER.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THERE WERE 5 POST-IMPLANTATION REFRACTIVE SURPRISES REQUIRING RE-IMPLANTATION OVER THE PAST YEAR. THIS IS THE INFO FOR PT 1/5. IT WAS REPORTED THAT AFTER UNDERGOING SURGICAL PROCEDURES ON BOTH EYES TO IMPLANT INTRAOCULAR LENSES (OS ON (B)(6) 2012; OD ON (B)(6) 2012), THE PATIENT EXPERIENCED POOR POST-OPERATIVE OUTCOMES: STABLE MANIFEST REFRACTION OF -1.25 + 0.75 X 040 (OD) AND -2.00 + 1.25 X 015 (OS) ON (B)(6) 2013. THE PT IS SCHEDULED FOR RE-IMPLANTATION SURGERY ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136915 IOLMASTER 500 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA SITE) 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention