BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2115601 · Received May 20, 2011

    Report

    Report Number
    1119421-2011-00622
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    January 25, 2010
    Report Date
    April 22, 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
    TN, 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: THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THE SAMPLE WAS NOT RETURNED. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. CONCLUSIONS: 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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 04/26/2011 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 04/27/2011. MEDICAL RECORDS WERE RECEIVED ON 04/22/2011. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO THE PT EXPERIENCING GLARE. IN A F/U THE DIR OF SURGERY CONCIERGE REPORTED THE PT REPORTED SEEING COBWEBS OVER HER VISION, SHADOWS ON LETTERS AND NEAR VISION NOT BEING GOOD APPROX SIX WEEKS FOLLOWING HER IOL IMPLANT PROCEDURE. THE PT WAS STARTED ON MEDICATIONS FOR DRY EYES FOR SEVERAL MONTHS; HOWEVER, THE PT WAS UNABLE TO ADJUST. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL LENS. FOLLOWING THE EXCHANGE PROCEDURE, THE PT WAS REPORTED TO BE VERY HAPPY WITH HER OUTCOME. SHE REPORTED SHE COULD SEE WELL AT DISTANCE AS WELL AS CLOSE. THE SURGEON REPORTED THE EVENT RESOLVED FOLLOWING THE IOL EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10870503

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention UNK VISCOELASTIC| ARTIFICIAL TEARS| VISCOAT| BSS| RESTASIS| HEALON