BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2191133 · Received July 29, 2011

    Report

    Report Number
    1119421-2011-00947
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    January 26, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 07/07/2011 BY FAX AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 07/22/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT SEEING STARBURSTS AND RINGS OF LIGHT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A F/U, THE SURGEON REPORTED THAT AN LRI (LIMBAL RELAXING INCISION) PROCEDURE WAS PERFORMED APPROX FOUR MONTHS FOLLOWING THE IMPLANT SURGERY. THE SURGEON ALSO REPORTED NOTING POSTERIOR CAPSULE OPACIFICATION AND PERFORMED A YAG LASER. THE SURGEON REPORTED THE PT CONTINUES TO EXPERIENCE GLARE, HALOS, AND STARBURSTS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10902140

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention PROVISC