BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 1971102 · Received January 26, 2011

    Report

    Report Number
    2648035-2011-00002
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS DISCARDED BY THE ACCOUNT AND NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE CAUSE OF THE HAPTIC DISTORTION IS NOT KNOWN BUT APPEARS TO HAVE OCCURRED DURING THE IMPLANTATION OF THE LENS. OUR INVESTIGATION RESULTS ARE INCONCLUSIVE. ALL CURRENTLY AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT WHEN THE PATIENT RETURNED FOR THEIR ONE DAY POST-OP VISIT FOLLOWING ROUTINE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT THE SURGEON NOTED THE HAPTIC APPEARED "BUNCHED UP". THE INCISION WAS ENLARGED AND THE IMPLANTED LENS WAS REMOVED AND REPLACED WITHOUT COMPLICATION. THERE WAS NO PATIENT INJURY REPORTED. THE REMOVED IOL, BOX AND PAPERWORK WERE ALL THROWN AWAY AT THE SURGERY CENTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention