BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2963936 · Received February 15, 2013

    Report

    Report Number
    9614546-2013-00022
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IOL WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION SHOWED A LENS WHERE THE OPTIC WAS CUT IN HALF; NO OPTICAL DEVIATIONS ON THE OPTIC PARTS COULD BE FOUND. THE IOL PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS. BATCH RECORDS WERE REVIEWED, NO DEVIATIONS WERE NOTED AND THE LENS WAS WITHIN SPECIFICATION WHEN RELEASED TO MARKET. ALL PERTINENT INFORMATION AVAILABLE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED AFTER IT BECAME ''TILTED'' (DISLOCATED) IN THE EYE. A REGULAR SIZE INCISION WAS MADE, THE LENS CUT IN TWO FOR THE REMOVAL. DURING THE SAME PROCEDURE A SECOND IOL WAS IMPLANTED IN THE SULCUS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67440 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention