BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 1831514 · Received September 10, 2010

    Report

    Report Number
    2648035-2010-00180
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080/S06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND MEASURED FOR DIOPTER. THE RESULTS WERE CONSISTENT WITH THE LABELED DIOPTER OF 21.50. ALL OTHER OPTICAL MEASUREMENTS MET MANUFACTURING SPECIFICATIONS. THESE RESULTS REASONABLY SUGGEST THIS ISSUE IS NOT MANUFACTURING RELATED. WE WILL CONTINUE TO MONITOR AND TREND ALL RESULTS.

    Additional Manufacturer Narrative · 1

    THE IOL WAS NOT YET BEEN RECEIVED FOR ANALYSIS. THE DEVICE MET ALL SPECIFICATIONS PRIOR TO MARKET RELEASE. THERE WAS NO REPORT OF PATIENT INJURY RECEIVED. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND ALL REPORTS RECEIVED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED FAILURE CODE 500:320:844:0000. IT IS UNKNOWN WHEN OR AT WHAT POINT IN THE PROCESS THIS CONDITION OCCURRED. REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT THIS CONDITION INTERRUPTED DELIVERY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.04.00, WHICH IS CLASSIFIED AS UNREMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITHOUT COMPLICATION 10 MONTHS AFTER IMPLANT. REASON STATED WAS THE IMPROPER IOL POWER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MONOFOCAL LENS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention