BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 293344 · Received August 25, 2000

    Report

    Report Number
    2028159-2000-00205
    Event Type
    Malfunction
    Date Received
    August 25, 2000
    Report Date
    July 26, 2000
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR NOTED DAMAGED CORNERS WITH OPEN SEALS ON THE FIRST TWO OUT OF SIX PACKS IN THE CARTON. SHIPPING CARTON HAD NO VISIBLE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS OPHTHALMIC SURGERY SYSTEM HQE ALCON - IRVINE TECHNOLOGY CTR ACCURUS 400VS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA