BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1120673 · Received August 14, 2008

    Report

    Report Number
    1119421-2008-00591
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    January 30, 2008
    Report Date
    July 15, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED 07/16/2008, 07/18/2008 AND 07/24/2008 BY PHONE, FAX AND MAIL. ADD'L INFO WAS RECEIVED ON 07/16/2008 AND 07/28/2008. A COMPLETED QUESTIONAIRE WAS RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS HAVING A PT THAT HAS HAD NEGATIVE DYSPHOTOPSIA FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ONE DAY POSTOPERATIVELY, THE PT REPORTED SEEING A LINE OF LIGHT. ON THE EIGHT POSTOPERATIVE DAY, SHE REPORTED SEEING A DARK SEMI CIRCLE IN HER VISION. IN A F/U, THE SURGEON REPORTS THE OUTCOME OF EVENT FOR THE PT AS "GOOD." THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON SN60WF 10764378

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other VISCOAT| NEVANAL| VIGAMOX