BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1120670 · Received August 14, 2008

    Report

    Report Number
    1119421-2008-00592
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    January 4, 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. ADDITIONAL INFORMATION WAS REQUESTED 07/16/2008, 07/18/2008 AND 07/24/2008 BY PHONE, FAX AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED 07/16/2008 AND 07/28/2008. A COMPLETED QUESTIONNAIRE 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 BAND OF LIGHT. FOUR DAYS POSTOPERATIVELY, THE PT REPORTED SEEING A MOON SHAPED OBJECT IN HER VISION. SINCE THE EIGHTH POSTOPERATIVE DAY, THE PT HAS REPORTED SEEING A DARK ARC IN HER VISION. IN A FOLLOW UP, THE SURGEON REPORTS THE OUTCOME OF EVENT FOR THE PATIENT AS "GOOD". THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10736203

    Patients

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