BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 2230498 · Received August 12, 2011

    Report

    Report Number
    2028159-2011-00949
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL PHARMACIST REPORTED THAT DURING A PROCEDURE, THE SURGEON OBSERVED METALLIC DEPOSITS IN THE INCISION SITE, AS WELL AS A SLIGHT BURN OFF THE SCLERAL INCISION WHILE USING A FRAGMATOME HANDPIECE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO BUT NONE HAS BEEN RECEIVED THUS FAR.

    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 Required Intervention FRAGMENTATION HANDPIECE