BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1034588 · Received April 2, 2008

    Report

    Report Number
    1119421-2008-00204
    Event Type
    Other
    Date Received
    April 2, 2008
    Date of Event
    February 6, 2008
    Report Date
    March 3, 2008
    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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PROD HISTORY RECORD REVIEW INDICATED THE PROD MET RELEASE CRITERIA. THERE ARE NO OTHER REPORTS IN THE LOT. ADD'L INFO WAS REQUESTED BY MAIL AND BY FAX ON 03/07/2008 AND BY PHONE ON 03/21/2008. A COMPLETED QUESTIONAIRE WAS REC'D FROM THE SURGEON. THIS REPORT WAS MAILED TO FDA ON: 04/02/2008.

    Description of Event or Problem · 1

    A CUSTOMER REPORTS SHARP PAIN, GRITTINESS, WATERY EYES, PHOTOSENSITIVITY AND FLOATERS FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. IN A F/U, THE SURGEON REPORTS OUTCOME OF EVENT AS "POOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD / HUNTINGTON SN60AT 10605751

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other