BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 512350 · Received February 20, 2004

    Report

    Report Number
    1644019-2004-00006
    Event Type
    Injury
    Date Received
    February 20, 2004
    Date of Event
    January 21, 2004
    Report Date
    January 22, 2004
    Manufacturer
    ALCON - HOUSTON
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED RECENT CHANGE TO STOPPER DESIGN IN THE SILICONE OIL INJECTION KTI CREATES PRESSURE BUILD-UP IN SYRINGE AND SUDDEN SEPARATION OF COMPONENTS. THIS LOUD EXPLOSION STARTLED SURGEON WHILE HOLDING INSTRUMENT IN EYE; A LARGE RETINAL LACERATION AND CHOROIDAL HEMORRHAGE OCCURRED. REQUIRED CONTROL OF INTRAOCULAR HEMORRHAGE AND REPAIR OF RETINAL LACERATION. PATIENT WAS HOSPITALIZED. SEVERE VISUAL LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS OPHTHALMIC SURGERY SYSTEM HQE ALCON - HOUSTON ACCURUS 800CS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization