BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2230503 · Received August 12, 2011

    Report

    Report Number
    1119421-2011-00979
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 12, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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 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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 07/18/2011 BY FAX AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 07/22/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT ON THE FIRST DAY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE SURGEON NOTED THE IOL HAD MOVED. THE SURGEON REPOSITIONED THE LENS IN A SECONDARY SURGICAL PROCEDURE. THE CONSUMER REPORTED HE WAS TOLD HIS EYES WERE DRY AND HAD BEEN PRESCRIBED ARTIFICIAL TEARS. THE CONSUMER STATED HIS VISION IS STILL VERY FOGGY. IN A F/U, THE SURGEON REPORTED THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE EVENT RESOLVED FOLLOWING THE OIL REPOSITION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 11019241

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention DUOVISC: UNK MONARCH CARTRIDGE AND| HANDPIECE| UNK GLAUCOMA DROPS