BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3051573 · Received April 10, 2013

    Report

    Report Number
    2648035-2013-00162
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION RESULTS REVEALED THE LENS HAD ONE DISTORTED HAPTIC AND APPEARS TO HAVE EVIDENCE OF VISCOELASTIC. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WHEREBY THERE WAS A LOADING ERROR RESULTING IN A BROKEN HAPTIC. AN INCISION ENLARGEMENT WAS MADE TO REMOVE AND REPLACE THE LENS OF SAME DIOPTER POWER WITHIN THE SAME PROCEDURE. IT WAS STATED THAT THERE WAS NO ADVERSE EVENT CAUSED BY THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153147 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention EMERALD CARTRIDGE