BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 899232 · Received August 17, 2007

    Report

    Report Number
    1119421-2007-00344
    Event Type
    Injury
    Date Received
    August 17, 2007
    Date of Event
    July 5, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    KYB
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT. ADDITIONAL INFORMATION REQUESTED 07/20/2007, 07/23/2007, 07/25/2007 AND 07/30/2007 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION RECEIVED 07/25/2007, 07/31/2007 AND 08/07/2007 BY PHONE AND MAIL.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE CARTRIDGE SPLIT AND THE IOL ENTERED THE POSTERIOR CHAMBER SO RAPIDLY THAT THE LEADING HAPTIC WENT THROUGH THE POSTERIOR CAPSULE. THE LENS WAS REMOVED AND SUCCESSFULLY REPLACED WITH ANOTHER LENS IN THE SULCUS. THE SURGEON REPORTS A GOOD OUTCOME FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSERT DELIVERY SYSTEM LENS GUIDE KYB ALCON LABORATORIES, INC./HUNTINGTON NA 167387

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention IRRIGATING SOLUTION| BSS WITH EPI| PROVISC| VANCOMYCIN