BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 6111705 · Received November 17, 2016

    Report

    Report Number
    9614546-2016-00609
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    September 30, 2016
    Report Date
    April 20, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    UDI-DI
    05050474560086
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE INSPECTION COULD NOT BE PERFORMED, THEREFORE THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE INTRAOCULAR LENSES. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZKB00 20.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM THE RIGHT EYE OF A FEMALE PATIENT DUE TO AN UNEXPECTED POST UP REFRACTION. LENS WAS REPLACED WITH THE SAME MODEL LENS BUT WITH A 19.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. NO PATIENT INJURY POST-OP AND PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759141 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZKB00 05050474560086

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention