Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 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.

Code information: Serial numbers: SPC00146, SPC00148, SPC00181, SPC00362, SPC00384, SPC00393, SPC00403, SPC00406, SPC00418, SPC00422, SPC00424, SPC00427, SPC00466, SPC00469, SPC00500, SPC00504, SPC00524, SPC00525, SPC00566, SPC00636, SPC00738, SPC00771, SPC00785, SPC00793, SPC00802, SPC00839, SPC00851, SPC00889, SPC00926, SPC00966, SPC00969, SPC01002, SPC01035, SPC01159, SPC01167, SPC01213, SPC01218, SPC01224, SPC01263, SPC01267, SPC01300, SPC01347, SPC01405, SPC01442, SPC01446, SPC01447, SPC01449, SPC01466, SPC01474, SPC01492, SPC01542, SPC01573, SPC01608, SPC01629, SPC01653, SPC01655, SPC01666, SPC01667, SPC01678, SPC01681, SPC01687, SPC01696, SPC01699, SPC01707, SPC01732, SPC01742, SPC01746, SPC01749, SPC01750, SPC01752, SPC01754, SPC01756, SPC01760, SPC01816, SPC01817, SPC01819, SPC01820, SPC01843 and SPC01884

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.