BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2991273 · Received March 6, 2013

    Report

    Report Number
    9614546-2013-00042
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    October 25, 2012
    Report Date
    February 15, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH RECORDS WERE REVIEWED AND WERE WITHIN SPECIFICATIONS; NO DEVIATIONS WERE NOTED. PRIOR TO RELEASE TO MARKET, THE IOL MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IT WAS FURTHER REPORTED THAT THE EXPLANTED LENS IN THE RIGHT EYE WAS A 19.5 DIOPTER LENS AND WAS REPLACED WITH AN 18.5 DIOPTER LENS. THE INTRAOCULAR LENS (IOL) WAS RETURNED TO OUR MANUFACTURING FACILITY FOR EVALUATION. A VISUAL INSPECTION SHOWED A LENS WHERE THE OPTIC WAS CUT IN HALF, ONE PART WAS NOT PRESENT. NO OPTICAL DEVIATIONS ON THE PRESENT OPTIC PART WERE FOUND. THE LENS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE AFTER THE DOCTOR NOTED THAT IT WAS POORLY POSITIONED. ANOTHER LENS WAS IMPLANTED DURING THE SAME PROCEDURE. THE ORIGINAL INCISION WAS NOT ENLARGED AND THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96175 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention