BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3020229 · Received March 25, 2013

    Report

    Report Number
    9614546-2013-00054
    Event Type
    Injury
    Date Received
    March 25, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION F COMPLETED BY MANUFACTURER.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WHICH WAS RE-CENTERED IN A SECONDARY PROCEDURE BY A CONSULTING PHYSICIAN. IN ADDITION TO THE RE-CENTERING OF THE LENS, THE PATIENT HAD A YAG CAPSULOTOMY PERFORMED, DUE TO BLURRY VISION AFTER THE RECENTERING OF THE LENS, WHICH WAS STATED TO HAVE BEEN MINIMALLY BENEFICIAL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122030 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention