BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2950886 · Received February 8, 2013

    Report

    Report Number
    9614546-2013-00014
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    November 26, 2012
    Report Date
    January 25, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE MANUFACTURING RECORDS WERE REVIEWED AND SHOW NO DEVIATIONS. DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WERE VERIFIED AND WERE WITHIN SPECIFICATIONS. THIS IS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER 16.5 DIOPTER OF THIS LOT NUMBER.CONCLUSION: THE BATCH PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WERE WITHIN ALL SPECIFICATIONS.(B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE 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 LENS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT A PATIENT HAD AN INTRAOCULAR LENS REMOVED DUE DYSPHOTOPSIA. A MONOFOCAL LENS WAS PLACED DURING THE SAME PROCEDURE; AN INCISION ENLARGEMENT WAS NOT REQUIRED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55140 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention