BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3031428 · Received April 2, 2013

    Report

    Report Number
    2648035-2013-00143
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER. LENS WAS INSPECTED UNDER MICROSCOPE AT 10X AND IT WAS FOUND WITH STAINS, PARTICLES AND FIBERS ADHERED TO BOTH SIDES OF OPTIC BODY COMPATIBLE WITH HANDLING LENS IN AN UNSTERILE ENVIRONMENT. ALSO, ONE OF THE HAPTIC WAS OBSERVED BENT. THE BENT HAPTIC WAS ASSOCIATED WITH THE EXPLANT PROCESS. DIOPTER MEASUREMENT COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) OF THE LEFT OPTIC. IT WAS NOTICED DURING A POST OP EXAM THAT THE LENS HAD DECENTERED. THE DATE IS UNKNOWN WHEN IT WAS OBSERVED THAT THE LENS WAS DECENTERED. IT WAS REPORTED THAT THE LENS WAS REMOVED AND REPLACED ON (B)(6) 2013. IT WAS REPORTED THAT THE RESULTS WERE GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133784 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention