BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1790954 · Received August 4, 2010

    Report

    Report Number
    1119421-2010-00871
    Event Type
    Other
    Date Received
    August 4, 2010
    Report Date
    July 5, 2010
    Manufacturer
    ALCON RESEARCH LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE OR PROVIDE ANY FURTHER INFORMATION. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "VISION 0.2 (20/100)" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "FIBRIN DEPOSITS" (FOREIGN MATERIAL PRESENT IN DEVICE [IOL INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED, HE OBSERVED FIBRIN DEPOSITS ON FOUR INTRAOCULAR LENSES (IOL) IN APPROXIMATELY FOUR WEEKS. HE REMOVED THE FIBRIN DEPOSITS BY LASER. THE SURGEON REPORTED THE VISUAL ACUITY OF THE PATIENTS WAS 0.2 (20/100) DUE TO "HAZE" CAUSED BY FIBRIN DEPOSITS BEFORE THE LASER TREATMENT AND 1.0 (20/20 AFTER THE LASER TREATMENT. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE OR PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD / HUNTINGTON SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other