Bausch & Lomb Inc: Medical Device Recall in 2014 - (Recall #: Z-0862-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 4, 2014

Date Posted: December 31, 2014

Recall Number: Z-0862-2015

Event ID: 69717

Reason for Recall:

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

Status: Terminated

Product Quantity: 106

Code Information:

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 Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated