BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 3171181 · Received June 14, 2013

    Report

    Report Number
    2648035-2013-00249
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USED FOR EXPLANT OF INTRAOCULAR LENS (IOL). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LENS WAS RETURNED TO OUR MANUFACTURING FACILITY FOR INSPECTION. A VISUAL INSPECTION REVEALED A LENS THAT WAS CUT IN HALF AND WAS CONSISTENT WITH A LENS THAT HAD BEEN EXPLANTED. THE LENS WAS INSPECTED AT (B)(4) MAGNIFICATION AND REVEALED SURFACE RESIDUALS (FIBERS, PARTICLES AND STAINS) ON THE LENS SURFACE. SURFACE RESIDUE WAS COMPATIBLE WITH THE HANDLING THE LENS, SUCH AS DURING THE IMPLANT AND EXPLANT PROCESS. THERE WERE NO UNACCEPTABLE COSMETIC CONDITIONS RELATED TO THE MANUFACTURING PROCESS IN THE RETURNED LENS. NO MANUFACTURING RELATED DEFECT THAT COULD HAVE CAUSED A COMPLAINT RELATED TO A VISUAL DISTURBANCE WAS IDENTIFIED IN THE RETURNED LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED AFTER THE PATIENT EXPERIENCED ANISOMETROPIC SYMPTOMS. THE PATIENT IS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270550 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention