BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 1942960 · Received December 30, 2010

    Report

    Report Number
    2648035-2010-00258
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 25, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IOL WAS RECEIVED AND IS CURRENTLY BEING EVALUATED AT THE MANUFACTURING SITE, RESULTS ARE NOT YET AVAILABLE. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A SUPPLEMENT MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE RETURNED INTRAOCULAR LENS(IOL) WAS INSPECTED USING A SLIT LAMP PROCESS. RESULTS CONFIRM THE HAZE LEVEL OF THE IOL EXCEEDED MANUFACTURING SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS SHOW THE LENSES SAMPLED FROM THIS PRODUCTION ORDER MET HAZE LEVEL SPECIFICATIONS AT TIME OF RELEASE. OUR INVESTIGATION DID NOT IDENTIFY A DEFINITIVE CAUSE ASSOCIATED WITH THE MANUFACTURING PROCESS FOR THIS LATE ONSET OPTIC HAZE. THE COMPLAINT ANALYSIS RESULTS REMAIN INCONCLUSIVE.

    Description of Event or Problem · 1

    THE INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S EYE 2 YEARS AGO. IMMEDIATELY POST OPERATIVE THE PATIENT'S VISUAL ACUITY WAS 20/20 BUT HER VISION GRADUALLY DECREASED TO THE POINT WHERE THE LENS HAD TO BE EXPLANTED DUE TO A HAZY OPTIC.

    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