BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2821806 · Received November 6, 2012

    Report

    Report Number
    9614546-2012-00188
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 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

    THE EXPLANTED INTRAOCULAR LENS (IOL) WAS RETURNED TO OUR MANUFACTURING FACILITY FOR AN EVALUATION. A VISUAL INSPECTION SHOWED A LENS WHERE THE OPTIC WAS CUT IN HALF, NO OPTICAL DEVIATIONS ON THE OPTIC PARTS WERE FOUND. THIS CONDITION PRECLUDED BEING ABLE TO MEASURE THE DIOPTER. HOWEVER, THE LENS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS. THE DIOPTER MEASUREMENT RECORDS WAS VERIFIED AND SHOWED TO BE WITHIN SPECIFICATIONS. THIS WAS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER OF 13.5 DIOPTER FOR THIS LENS. THE BATCH HAS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. THE WORD DYSPHOTOPSIA WAS MISSPELLED IN THE EVENT DESCRIPTION TEXT: A PHYSICIAN REPORTED THAT A INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT WAS UNABLE TO ADAPT TO MULTIFOCALITY AND EXPERIENCED DYSPHOTOPSIA. A NEW IOL WAS IMPLANTED DURING THE SAME PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT WAS UNABLE TO ADAPT TO MULTIFOCALITY AND EXPERIENCED DYSPHTOPSIA. A NEW IOL WAS IMPLANTED DURING THE SAME PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    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 69 YR Required Intervention