BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 1915760 · Received December 6, 2010

    Report

    Report Number
    9614546-2010-00068
    Event Type
    Injury
    Date Received
    December 6, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE LENS WAS NOT RETURNED FOR ANALYSIS, AN EMPTY LENS BOX ONLY WAS RECEIVED. PRIOR TO RELEASE TO THE MARKET THE IOL MET ALL MANUFACTURING SPECIFICATIONS. WHILE WE WERE UNABLE TO DETERMINE THE CAUSE OF THIS EVENT OUR INVESTIGATION REASONABLY SUGGESTS IT IS NOT MANUFACTURING RELATED. DATE OF THE EVENT WAS NOT REPORTED.ALL AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    A NURSE REPORTED THE INTRAOCULAR LENS (IOL) HAPTIC DISTORTED DURING THE INITIAL SURGERY. THE INCISION WAS ENLARGED AND THE IOL REMOVED DURING THE SAME SURGERY, NO PATIENT INJURY. A NEW LENS WAS IMPLANTED WITHOUT COMPLICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other