BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURI PHACO PACK

    MDR report key: 2152526 · Received June 22, 2011

    Report

    Report Number
    1920664-2011-00056
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K033653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM FRANCE STATES "BUBBLES DURING PHACO STEP. NO PATIENT IMPACT." ADDITIONAL INFORMATION HAS BEEN REQUESTED YET NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURI PHACO PACK BASIC VENTURI PACK HQC BAUSCH & LOMB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1