BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MUTIFOCAL 1-PIECE

    MDR report key: 2213526 · Received August 16, 2011

    Report

    Report Number
    9614546-2011-00068
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    May 24, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RECEIVED AND INSPECTED UNDER 10X MAGNIFICATION SHOWING AN OPTIC CUT IN HALF WITH ONE BROKEN HAPTIC. DRIED MATERIAL WAS OBSERVED ON THE OPTIC. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. INFORMATION RECEIVED FROM THE SURGEON STATES THE LENS WAS DAMAGED DURING THE LOADING PROCESS PRIOR TO INSERTION INTO THE PATIENT'S EYE SUGGESTING THIS EVENT WAS NOT CAUSED BY A DEFICIENT LENS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A SURGEON REPORTED THE INTRAOCULAR LENS WAS DAMAGED WHILE LOADING INTO THE INSERTION SYSTEM. THE LENS WAS IMPLANTED AND DOCTOR NOTICED THE DAMAGE AND EXPLANTED THE LENS BY ENLARGING THE INCISION. NO PATIENT INJURY AND SURGERY WAS COMPLETED THE SAME DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other