BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3011428 · Received March 19, 2013

    Report

    Report Number
    2648035-2013-00126
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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 REMOVED AND REPLACED IN A SECONDARY SURGERY DUE TO A REFRACTIVE ERROR. IT WAS STATED THAT THE PATIENT''S VISUAL PREFERENCE WAS NOT COMMUNICATED TO THE DOCTOR RESULTING IN A SECONDARY PROCEDURE. IT WAS STATED THAT THERE WAS NO INCISION ENLARGEMENT AND NO PATIENT COMPLICATIONS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114758 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention