BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 1943366 · Received January 1, 2011

    Report

    Report Number
    2648035-2010-00259
    Event Type
    Injury
    Date Received
    January 1, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080/S06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS REMAINS IMPLANTED LIMITING OUR INVESTIGATION TO A REVIEW OF THE MANUFACTURING RECORDS. THIS REVIEW SHOWED NO DEVIATIONS DURING THE PROCESS. THE CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT IS UNDETERMINABLE AT THIS TIME. ALL INFORMATION CURRENTLY AVAILABLE IS INCLUDED IN THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. OTHER TEXT : IOL REMAINS IMPLANTED.

    Description of Event or Problem · 1

    FOLLOWING ROUTINE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT THE PATIENT'S VISUAL ACUITY WAS LOWER THAN EXPECTED, A MINUS 2.0 DIOPTER. THE LENS REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other