BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHACOEMULSIFICATION SYSTEM

    MDR report key: 3062929 · Received April 12, 2013

    Report

    Report Number
    1920664-2013-00099
    Event Type
    Injury
    Date Received
    April 12, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT REPORT WAS RECEIVED FROM A THIRD PARTY SOURCE. THE USER FACILITY HAS NOT PROVIDED ANY INFORMATION RELATED TO THIS EVENT. WE ARE SUBMITTING THIS REPORT BECAUSE THE INFORMATION RECEIVED INDICATED THE FACILITY USES A BAUSCH AND LOMB PHACO UNIT, ALTHOUGH IT IS NOT KNOWN IF A BAUSCH AND LOMB DEVICE WAS USED AT THE TIME OF THIS EVENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING A POSTERIOR HOLE WAS NOTICED BY THE SURGEON DURING PHACO THAT RADIATED ANTERIOR DURING I/A. AN ANTERIOR VITRECTOMY WAS PERFORMED AND THE IOL WAS PLACED IN THE SULCUS. NO FURTHER DETAILS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157777 PHACOEMULSIFICATION SYSTEM HQC BAUSCH & LOMB, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention