BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2933309 · Received January 29, 2013

    Report

    Report Number
    2648035-2013-00063
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRIOR TO RELEASE TO MARKET, THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER. THE SAMPLE WAS INSPECTED WITH A MICROSCOPE AT 10X MAGNIFICATION. VISUAL INSPECTION REVEALED SURFACE RESIDUALS (FIBERS, PARTICLES) ON THE LENS SURFACE THAT WERE COMPATIBLE WITH HANDLING THE LENS OUT OF A STERILE ENVIRONMENT. NO OTHER UNACCEPTABLE COSMETIC DEFECTS WERE FOUND IN THE RETURNED LENS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WOULD NOT POSITION IN THE PATIENT'S EYE DURING IMPLANT. THE LENS WAS REMOVED AND ANOTHER LENS IMPLANTED. DURING THE SECOND SURGICAL LENS IMPLANT, AN INCISION ENLARGEMENT WAS REQUIRED. THE PATIENT WAS TO SEE A RETINAL SPECIALIST POST OPERATIVELY. IN FOLLOW UP IT WAS REPORTED THAT THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38450 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention