BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL II

    MDR report key: 2062311 · Received March 16, 2011

    Report

    Report Number
    1644019-2011-00011
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    February 14, 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
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS RETURNING. A ROOT CAUSE IS UNK AT THIS TIME. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 03/16/2011. (B)(4).

    Description of Event or Problem · 1

    THE REP OF A DOCTOR'S OFFICE REPORTED THAT DURING SURGERY, THE PEDAL WOULD NOT REFLOW. THE SURGERY WAS CONCLUDED SUCCESSFULLY. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL II PHACOEMULSIFICATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER UNIV II NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK