BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1232210 · Received November 14, 2008

    Report

    Report Number
    1119421-2008-00916
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 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
    MA, 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 ON 10/17/2008 AN 10/20/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/21/2008. THIS REPORT WAS MAILED TO FDA ON: 11/14/2008.

    Description of Event or Problem · 1

    AN OR TECHNICIAN REPORTS THREE PATIENTS WITH INFECTIONS ONE DAY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PATIENT WAS TREATED WITH MEDICATIONS. IN A FOLLOW-UP, THE SURGEON REPORTS THE PROGNOSIS FOR THE PATIENT AS "GOOD". THIS MEDICAL DEVICE REPORT IS FOR THE FIRST PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SN60WF 10834985

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention VISCOAT| TETRACAINE| BSS+