BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3162986 · Received June 11, 2013

    Report

    Report Number
    2648035-2013-00242
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUAL INSPECTION OF THE RETURNED PRODUCT REVEALED THE LENS HAD ONE DETACHED HAPTIC, TORN OPTIC AND APPEARS TO HAVE EVIDENCE OF VISCOELASTIC, OVD, (OPHTHALMIC VISCOSURGICAL DEVICE). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. (B)(4).

    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 THE SAME PROCEDURE WHEN THE SURGEON OBSERVED A BENT HAPTIC. THE INCISION WAS ENLARGED TO 3MM. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262195 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention