BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1821665 · Received August 25, 2010

    Report

    Report Number
    1119421-2010-00930
    Event Type
    Other
    Date Received
    August 25, 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
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    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 HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "SEEING EDGE OF LENS" (VISUAL DISTURBANCES). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE COULD SEE THE EDGE OF HER LENS. IN A FOLLOW UP PHONE CALL WITH THE SURGEON'S OFFICE, THE PT WAS REPORTED TO BE EXPERIENCING DYSPHOTOPSIA. POSTERIOR CAPSULE OPACIFICATION HAS BEEN OBSERVED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 11003763

    Patients

    Seq Age Sex Outcome Treatment
    1 Other