BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHACOEMULSIFICATION SYSTEM

    MDR report key: 3062902 · Received April 12, 2013

    Report

    Report Number
    1920664-2013-00100
    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 IN USE AT THE TIME OF THIS EVENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THERE WAS AN ANTERIOR TEAR DURING PHACO. THERE WAS NO VITREOUS LOSS. THE IOL WAS PLACED IN THE BAG. NO FURTHER DETAILS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157556 PHACOEMULSIFICATION SYSTEM HQC BAUSCH & LOMB, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other