BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1062471 · Received June 18, 2008

    Report

    Report Number
    1119421-2008-00450
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 19, 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
    IL, 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 HAS BEEN REQUESTED ON 05/21/2008 AND 06/03/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 06/06/2008. THIS EVENT MEETS CRITERIA FOR POTENTIAL TASS.

    Description of Event or Problem · 1

    A SURGEON REPORTS HAVING A PT WITH ENDOPHTHALMITIS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. AT AN OFFICE VISIT SIX DAYS FOLLOWING SURGERY, THE PT REPORTED A FILM OVER HER EYE AND SEEING FLOATERS. SHE WAS TREATED WITH MEDICATIONS. VITREOUS CULTURES WERE TAKEN. RESULTS ARE NOT KNOWN. THE PT WAS REFERRED TO A RETINAL CONSULTANT. IN A FOLLOW-UP, THE SURGEON REPORTS OUTCOME OF EVENT FOR PT AS "UNK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10764208

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other LUMIGAN