BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2251454 · Received September 14, 2011

    Report

    Report Number
    9612169-2011-00051
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. ACTIONS: THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS LOT. INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. NO FURTHER ACTION IS WARRANTED AT THIS TIME. FINAL COMMENTS: BASED ON OUR CURRENT TRENDS, 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 HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A PT EXPERIENCED POOR NEAR VISION AND DOUBLE VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTROCULAR LENS MFK ALCON LABORATORIES IRELAND LTD. SN6AD1 21005459

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other