BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCURUS 800CS

    MDR report key: 2023653 · Received March 4, 2011

    Report

    Report Number
    2028159-2011-00203
    Event Type
    Other
    Date Received
    March 4, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PT'S EYE COLLAPSED DURING A VITRECTOMY PROCEDURE. IN A F/U, THE NURSE REPORTED THAT THERE WAS NO HARM OR INJURY TO THE PT AS A RESULT OF THE COLLAPSE. SHE ALSO STATED THERE HAVE BEEN OTHER PTS WHO HAVE EXPERIENCED A SOFT EYE DURING SURGERY. THERE WAS NO ADDITIONAL TREATMENTS REQUIRED OR HARM TO THESE PTS. THE NURSE WAS UNABLE TO PROVIDE ADDITIONAL DETAILS OR PT IDENTIFIERS RELATED TO THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other