BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2921203 · Received January 17, 2013

    Report

    Report Number
    2648035-2013-00021
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 28, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 AND STAINS) ON THE LENS SURFACE THAT WERE COMPATIBLE WITH THE EXPLANT PROCEDURE. THE INTRAOCULAR LENS (IOL) HAD A LARGE CUT IN THE OPTIC. THIS CONDITION MAY BE A CONSEQUENCE OF THE REMOVAL PROCESS OF THE LENS FROM THE EYE. NO OTHER COSMETIC DEFECT COULD BE IDENTIFIED IN THE LENS RECEIVED. NO MANUFACTURING RELATED TO OR THAT COULD HAVE CAUSED ISSUES OF CAPSULE TEAR AND INCISION ENLARGED, WERE VERIFIED IN THE SAMPLE RETURNED. ADDITIONALLY, THE PHYSICIAN INDICATED THE EVENTS WERE RELATED TO PATIENT ANATOMY ISSUES. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2012. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTATION OF A INTRAOCULAR LENS (IOL). DURING THE IMPLANTATION, IT WAS NOTED THAT THERE WAS A CAPSULAR TEAR WHICH WAS STATED TO BE CAUSED BY PATIENT PATHOLOGY AND NOT THE LENS ITSELF. IN ADDITION, THE SURGEON CREATED AN ENLARGED INCISION TO REMOVE THE LENS AND IMPLANTED AN ANTERIOR CHAMBER LENS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26118 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention