BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAUSCH & LOMB STELLARIS PHACOEMULSIFICATION SY

    MDR report key: 2153340 · Received June 30, 2011

    Report

    Report Number
    1920664-2011-00075
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM SPAIN STATES: "DURING THE SURGERY, ONLY WITH THE IRRIGATION IN THE EYE, THE EYE LOST PRESSURE/TONE AND THE PT HAD INJURIES BECAUSE THE CHOROID LAYER FELL. ALTHOUGH THE VACUUM VALUE IS NEGATIVE WHEN THE FOOT CONTROL IS NOT PRESSED." ADDITIONAL INFO HAS BEEN REQUESTED YET NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAUSCH & LOMB STELLARIS PHACOEMULSIFICATION SY HQC BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1