BEUDAMED
    FDA Recall Terminated

    Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.

    Recall: Z-0864-2015 · Initiated November 4, 2014

    Recall

    Recall Number
    Z-0864-2015
    Event Number
    69717
    Firm
    Bausch & Lomb Inc
    FEI Number
    1920664
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    November 4, 2014
    Posted
    December 23, 2014
    Terminated
    March 23, 2017
    Address
    3365 Tree Court Industrial Blvd, Saint Louis, MO, 63122-6615

    Description

    Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.

    Reason

    A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.

    Action

    Bausch & Lomb contacted customers by phone on November 4, 2014. Customers were informed of the conditions required for the device to malfunction. Customers were also notified that a software update to address the situation will be installed in their system within the next few weeks, and that the firm's service team will be scheduling a visit to each facility to install this software update. Customers were also told that in the meantime they may continue to use the device. For further questions please call (585) 338-6839.

    Distribution

    Worldwide Distribution - USA Distribution including to the states of AL, CA, CT, FL, GA, HI, IL, IN, KS, MI, MN, MO, MS, NH, NY, OH, OK, PA, TX, WI and WV., and to the countries of Austria, Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Italy, Jordan, Malaysia, Morocco, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Turkey and the United Arab Emirates.

    Quantity

    2