BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 3253268 · Received July 29, 2013

    Report

    Report Number
    2648035-2013-00308
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS(IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION NOTED THAT THE LENS WAS CUT IN HALF. THE RETURNED SAMPLE WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION. VISUAL INSPECTION REVEALED SOME SURFACE RESIDUE ON THE LENS COMPATIBLE WITH HANDLING,SUCH AS DURING THE IMPLANT AND EXPLANT PROCESS. NO MANUFACTURING RELATED ISSUES THAT MAY HAVE CAUSED THIS CONDITION WAS IDENTIFIED IN THE SAMPLE RETURNED. THE CONDITION OF THE LENS RECEIVED IS A RESULT OF THE EXPLANT PROCESS AND WAS NOT THE CONDITION OF THE LENS WHEN IT WAS USED IN THE PATIENT. MANUFACTURING RECORDS WERE REVIEWED AND SHOWED THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. EXPIRATION DATE 10/05/2014. DEVICE MANUFACTURING DATE 10/05/2009. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. IT WAS STATED THAT THE PATIENT EXPERIENCED SYMPTOMS OF MYOPIA AND ASTIGMATISM POST OP WHICH REQUIRED THE LENS TO BE EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352527 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention