BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE MULTIFOCAL

    MDR report key: 1980809 · Received February 7, 2011

    Report

    Report Number
    2648035-2011-00006
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 12, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED AND THE DIOPTER INSPECTION RESULTS SHOWED THE LENS IS 19.0 DIOPTER. THESE RESULTS ARE CONSISTENT WITH THE LABELED DIOPTER FOR THIS LENS. THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED AND SENT TO THE MANUFACTURING SITE FOR ANALYSIS WHICH IS CURRENTLY ONGOING. LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL INFORMATION CURRENTLY AVAILABLE IS INCLUDED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LENS WAS EXPLANTED 5 WEEKS AFTER IMPLANT DUE TO A REFRACTIVE SURPRISE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS 1-PIECE MULTIFOCAL MULTIFOCAL IOL MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention