BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2130191 · Received June 10, 2011

    Report

    Report Number
    1119421-2011-00735
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 13, 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
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: 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 INFORMATION. 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. ADDITIONAL INFORMATION WAS REQUESTED ON 05/16/2011 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 05/19/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER'S FIANCEE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE CONSUMER CANNOT SEE OUT OF HER EYE AND SEES THE FIVE RINGS FROM THE LENS "LIKE A GIANT CLOUD." IN A FOLLOW-UP, THE SURGEON REPORTED THAT POSTERIOR CAPSULE OPACIFICATION (PCO) WAS NOTED AND A YAG PROCEDURE WAS PERFORMED. THE PATIENT CONTINUES TO SEE CONCENTRIC CIRCLES. ADDITIONAL INFORMATION FROM INDICATED THAT AN UNAPPROVED VISCOELASTIC WAS USED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10916982

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEALON