BEUDAMED
    FDA Enforcement Class II Terminated

    Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY

    Recall: Z-0862-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0862-2015
    Event ID
    69717
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bausch & Lomb Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 31, 2014
    Initiation Date
    November 4, 2014
    Classification Date
    December 23, 2014
    Termination Date
    March 23, 2017
    Address
    3365 Tree Court Industrial Blvd, Saint Louis, MO, 63122-6615, United States

    Description

    Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY

    Reason

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

    Code Info

    Serial numbers: SPC01790, SPC01791, SPC01792, SPC01793, SPC01794, SPC01795, SPC01796, SPC01797, SPC01798, SPC01799, SPC01800, SPC01801, SPC01802, SPC01803, SPC01806, SPC01807, SPC01808, SPC01809, SPC01810, SPC01811, SPC01899, SPC01900, SPC01901, SPC01902, SPC01903, SPC01909, SPC01910, SPC01911, SPC01920, SPC01921, SPC01922, SPC01923, SPC01927, SPC01928, SPC01929, SPC01930, SPC01931, SPC01932, SPC01939, SPC01943, SPC01944, SPC01945, SPC01946, SPC01947, SPC01948, SPC01950, SPC01951, SPC01952, SPC01953, SPC01954, SPC01955, SPC01956, SPC01957, SPC01958, SPC01961, SPC01963, SPC01968, SPC01969, SPC01975, SPC01980, SPC01981, SPC01982, SPC01983, SPC01995, SPC01996, SPC01997, SPC02004, SPC02005, SPC02006, SPC02007, SPC02008, SPC02009, SPC02010, SPC02011, SPC02012, SPC02013, SPC02014, SPC02020, SPC02029, SPC02030, SPC02037, SPC02043, SPC02051, SPC02052, SPC02053, SPC02056, SPC02057, SPC02059, SPC02061, SPC02067, SPC02068, SPC02073, SPC02074, SPC02075, SPC02076, SPC02077, SPC02099, SPC02108, SPC02109, SPC02110, SPC02111, SPC02112, SPC02113, SPC02114, SPC02115 and SPC02120

    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

    106