BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE MULTIFOCAL

    MDR report key: 2001955 · Received February 27, 2011

    Report

    Report Number
    9614546-2011-00005
    Event Type
    Injury
    Date Received
    February 27, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RECEIVED AND SENT TO THE MANUFACTURER FOR ANALYSIS. LENS MET ALL SPECIFICATIONS PRIOR TO RELEASE. IN FOLLOW-UP IT WAS LEARNED THE INITIAL IMPLANT WAS REPLACED WITH THE SAME MODEL LENS 1.5 DIOPTERS HIGHER SUGGESTING THIS INCIDENT WAS NOT CAUSED BY THE PRODUCT. ALL CURRENTLY AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED INTRAOCULAR LENS SHOWED A HEAVILY DAMAGED OPTIC, PRECLUDING DIOPTER MEASUREMENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS. THE DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WERE VERIFIED AND SHOWED TO BE WITHIN SPECIFICATIONS. THIS IS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER 19.5 DIOPTER OF THIS LOT NUMBER. A REVIEW OF THE HISTORICAL COMPLAINT DATA BASE REVEALED THAT NO OTHER COMPLAINTS FROM THIS LOT NUMBER WERE RECEIVED. ALL INFORMATION RECEIVED IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH A HIGHER DIOPTER IOL WITHOUT COMPLICATION 3 WEEKS AFTER IT WAS IMPLANTED. THE REASON STATED WAS WRONG POWER IMPLANTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS 1-PIECE MULTIFOCAL MULTIFOCAL IOL MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention