BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1413196 · Received July 10, 2009

    Report

    Report Number
    1119421-2009-00667
    Event Type
    Injury
    Date Received
    July 10, 2009
    Date of Event
    February 1, 2009
    Report Date
    June 12, 2009
    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. ADDITIONAL INFORMATION WAS REQUESTED ON 06/15/2009 AND 06/18/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WAS OBTAINED BY PHONE ON 06/18/2009.

    Description of Event or Problem · 1

    A RECOVERY ROOM MANAGER REPORTED A PATIENT WHO PRESENTED WITH AN EYE INFECTION APPROXIMATELY FOUR WEEKS AFTER INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE SURGEON REPORTED THAT THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST AND WAS TREATED WITH MEDICATION. HE ALSO STATED THAT THE PATIENT IS DOING WELL, WITH A VISUAL ACUITY OF 20/30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10833529

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention