BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2170138 · Received June 22, 2011

    Report

    Report Number
    1119421-2011-00782
    Event Type
    Other
    Date Received
    June 22, 2011
    Date of Event
    March 1, 2010
    Report Date
    May 23, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: 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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 05/26/2011 AND 06/16/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT TWO MONTHS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE HAS "CLOUDINESS" FROM THE LEFT HAND SIDE OF THE LENS. HE STATED THAT SUNGLASSES HELP TO ALLEVIATE THIS. THE SURGERY WAS PERFORMED IN 2010. HE REPORTED THAT HIS SURGEON REFERRED HIM TO ANOTHER SURGEON FOR A SECOND OPINION. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SA60AT 10945393

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other