BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2930272 · Received January 25, 2013

    Report

    Report Number
    2648035-2013-00050
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 10, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER. THE SAMPLE WAS INSPECTED WITH A MICROSCOPE AT 10X MAGNIFICATION POWER. VISUAL INSPECTION REVEALED SURFACE RESIDUALS (FIBERS, PARTICLES) ON THE LENS SURFACE. SURFACE RESIDUALS ARE COMPATIBLES WITH HANDLING THE LENS OUT OF STERILE ENVIRONMENT. NO OTHER UNACCEPTABLE COSMETIC DEFECTS WERE FOUND IN THE RETURNED LENS. NO DEFECT THAT COULD HAVE CAUSED COMPLAINT RELATED TO DISLOCATION AND LOADING ISSUE WAS VERIFIED IN THE SAMPLE RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4)-ENLARGED INCISION.PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS.(B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT OF AN INTRAOCULAR LENS (IOL) DUE TO DISPLACEMENT OF THE LENS IN THE OPTIC. IT WAS STATED THAT THE INCISION WAS ENLARGED TO REMOVE THE LENS, AND SUTURES WERE PLACED. IN ADDITION, IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY OR COMPLICATIONS. A NEW INTRAOCULAR LENS (IOL) WAS IMPLANTED. PATIENT WAS NOTED TO BE DOING WELL. NO FURTHER INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35307 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention