BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2030971 · Received March 4, 2011

    Report

    Report Number
    2028159-2011-00206
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 3, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 HOSPITAL THEATRE MANAGER REPORTED THAT A PT UNDERWENT VITRECTOMY AND MACULAR PEEL, RIGHT EYE. AT THE FIRST POST OPERATIVE EXAM WHICH WAS CONDUCTED FIVE DAYS POSTOPERATIVELY, THE PT REPORTED 'BUBBLES' IN HER VISION. A SMALL CLEAR SPHERICAL DROPLET, 0.5MM IN SIZE, WAS VISABLE FLOATING AGAINST THE RETINA AT THE 12:00 POSITION. IT IS SUSPECTED AS BEING OIL. IT WAS ONLY ABLE TO BE SEEN BY THE DOCTOR WITH THE MICROSCOPE. NO UNPLANNED TREATMENT OR SURGERY WAS REQUIRED AND THE OUTCOME IS REPORTED AS EXCELLENT.

    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 57 YR