BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2792749 · Received October 16, 2012

    Report

    Report Number
    9614546-2012-00170
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION SHOWS A LENS WERE THE OPTIC WAS CUT IN HALF, PRECLUDING DIOPTER MEASUREMENT. NO OPTICAL DEVIATIONS ON THE OPTIC PARTS COULD BE FOUND. THE RETURNED INTRAOCULAR LENS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A SURGERY CENTER REGARDING A FEMALE PATIENT WHO RECEIVED AN INTRAOCULAR LENS (IOL) ON (B)(6) 2012. FOLLOWING THE SURGERY THE FACILITY DETERMINED THE PATIENT WAS IMPLANTED WITH THE WRONG POWER LENS. THERE WAS NOTHING WRONG WITH THE LENS. ON (B)(6) 2012 THE LENS WAS EXPLANTED AND A NEW IOL WITH A DIFFERENT POWER WAS SUCCESSFULLY IMPLANTED. A NEW INCISION WAS MADE FOR THE EXPLANT; THE INITIAL INCISION WAS NOT ENLARGED. THE LENS WAS CUT IN HALF TO BE REMOVED. THERE WAS NO PATIENT INJURY OR COMPLICATIONS DURING THE SECOND PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention