BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 4760533 · Received May 8, 2015

    Report

    Report Number
    9614546-2015-00107
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    April 14, 2015
    Report Date
    April 16, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT A TECNIS ZLBOO 23.0 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE AFTER THE PATIENT COMPLAINED OF HALOS AND GLARE. THERE WERE NO SURGICAL COMPLICATIONS, SUCH AS AN INCISION ENLARGEMENT. THE IOL WAS REPLACED WITH ANOTHER TECNIS LENS. THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303569 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZLB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention