BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1821703 · Received August 27, 2010

    Report

    Report Number
    1119421-2010-00940
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "DECREASE IN SIGHT" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "SUSPECTED OPACIFICATION" (MATERIAL OPACIFICATION [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED THAT OPACIFICATION WAS DETECTED IN AN INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED IN 1997. THE SURGEON REPORTED THE PT HAD A DECREASE IN VISION. THE SURGEON REPORTED THE PT'S BCVA WAS 20/25 CURRENTLY AND HE WILL FOLLOW THE PT EVERY THREE TO FOUR MONTHS TO CHECK VISUAL ACUITY. POSTERIOR CAPSULE OPACIFICATION HAS BEEN OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60BM 415339

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other PROVISC| FOSINOPRIL| ARCOXIA