BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 1232208 · Received November 14, 2008

    Report

    Report Number
    1119421-2008-00907
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    KYB
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 11/14/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WHO DEVELOPED OCULAR INFLAMMATION TWO DAYS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. FURTHERMORE, THE PATIENT HAD A SUDDEN DECREASE OF VISUAL ACUITY. THE ANTERIOR CHAMBER AND VITREOUS WERE WHITE +++, TYNDALL ++; THERE WAS NO PAIN AND NO REDNESS. THE PT WAS TREATED WITH MEDICATIONS. PER REPORTER, THIS EVENT IS MORE INFLAMMATORY THAN INFECTIOUS. THE CAUSE OF THE EVENT IS NOT KNOWN. THERE ARE TWO MEDICAL DEVICE REPORTS BEING SUBMITTED FOR THIS REPORT. THIS REPORT IS FOR THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSERT DELIVERY SYSTEM LENS GUIDE KYB ALCON RESEARCH, LTD/HUNTINGTON NA 172820

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention BSS WITH ADRENALINE| PILOCARPINE| DUOVISC