BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2324742 · Received November 2, 2011

    Report

    Report Number
    1119421-2011-01331
    Event Type
    Injury
    Date Received
    November 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    October 3, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THERE ARE NO SIMILAR COMPLAINTS IN THE LOT. ADDITIONAL INFORMATION WAS REQUESTED BY PHONE, FAX AND MAIL ON 10/05/2011, 10/13/2011, 10/28/2011 AND 10/31/2011. ADDITIONAL INFORMATION WAS RECEIVED ON 10/13/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE NOTED "DIMINISHED ACUITY IN ORDINARY LIGHT LEVELS" COMPARED TO HIS FELLOW EYE WITH A CATARACT. THE CONSUMER ALSO NOTED "WHEN LOOKING TO LEFT SHOULDER, THERE ARE CONCENTRIC RING SHADOWS, LEFT LATERAL AND INFEROLATERAL FIELDS OF VIEW SEEM SLIGHTLY CURTAILED", AND "A SOLAR-RAY ARTIFACT", WHICH "AT TIMES THERE ARE FINE INTERRUPTED CONCENTRIC CIRCLES OF LIGHT". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10939925

    Patients

    Seq Age Sex Outcome Treatment
    1 Other