BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2830802 · Received November 13, 2012

    Report

    Report Number
    9614546-2012-00191
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS. THE DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WERE VERIFIED AND WERE SHOWN TO BE WITHIN SPECIFICATIONS. THIS WAS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER OF 19.0 DIOPTER FOR THIS LENS. THE BATCH PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    OUR ABBOTT MEDICAL OPTICS OFFICE IN (B)(6) RECEIVED A REPORT REGARDING A PATIENT WHO HAD A INTRAOCULAR LENS (IOL) EXPLANTED AND A NEW ONE IMPLANTED DUE TO ''BAD NEAR VISUAL ACUITY'.'

    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 63 YR Required Intervention