{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "131411", "product_res_number": "Z-0862-2015", "event_date_initiated": "2014-11-04", "event_date_posted": "2014-12-23", "recall_status": "Terminated", "event_date_terminated": "2017-03-23", "res_event_number": "69717", "product_code": "HQF", "k_numbers": [ "K133486" ], "product_description": "Bausch & Lomb Stellaris PC w/ Laser, BL14304\nThe responsible firm name is Bausch & Lomb Incorporated Rochester, NY", "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", "firm_fei_number": "1920664", "recalling_firm": "Bausch & Lomb Inc", "address_1": "3365 Tree Court Industrial Blvd", "city": "Saint Louis", "state": "MO", "postal_code": "63122-6615", "additional_info_contact": "Glenn M. Mattei\n585-338-6839", "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.", "root_cause_description": "Software Manufacturing/Software Deployment", "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.", "product_quantity": "106", "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.", "openfda": { "k_number": [ "K960971", "K041598", "K854949", "K862987", "K220877", "K895196", "K190448", "K842250", "K001772", "K834305", "K881494", "K232051", "K091064", "K051944", "K841856", "K133019", "K242397", "K031023", "K230350", "K883213", "K890509", "K842412", "K040209", "K894273", "K120825", "K251507", "K863591", "K130933", "K021538", "K031665", "K251772", "K860358", "K964751", "K895213", "K091581", "K832089", "K112154", "K973220", "K882372", "K853890", "K834610", "K844668", "K020374", "K882908", "K910532", "K131207", "K142830", "K873460", "K133358", "K885164", "K843965", "K091534", "K230722", "K243014", "K971950", "K981196", "K833232", "K201502", "K213592", "K223132", "K222395", "K904366", "K813492", "K123542", "K203130", "K874609", "K043236", "K850572", "K951079", "K063297", "K123056", "K081565", "K893630", "K894835", "K152688", "K023094", "K090774", "K854288", "K833533", "K153769", "K840854", "K932836", "K092621", "K010372", "K192045", "K791659", "K925663", "K910612", "K091981", "K841855", "K782065", "K231011", "K832316", "K781965", "K033941", "K935747", "K990075", "K233911", "K990665", "K844358", "K072823", "K932296", "K111460", "K833532", "K926470", "K852464", "K152603", "K081774", "K834060", "K220430", "K081946", "K842251", "K201623", "K212630", "K973193", "K893709", "K863246", "K904699", "K103547", "K840590", "K170302", "K061024", "K050541", "K220974", "K905453", "K840145", "K013760", "K942180", "K130195", "K931784", "K171488", "K903421", "K100253", "K190083", "K900199", "K952894", "K852234", "K232417", "K870839", "K122202", "K170067", "K230228", "K142398", "K844357", "K862568", "K801336", "K812219", "K872846", "K062074", "K240615", "K080423", "K222157", "K070776", "K100019", "K111643", "K050807", "K202760", "K103056", "K124043", "K180402", "K972514", "K852529", "K890086", "K960522", "K881134", "K910805", "K121187", "K062624", "K140362", "K864063", "K043613", "K140336", "K252979", "K181682", "K782106", "K142172", "K111108", "K833274", "K905141", "K875000" ], "pma_number": [ "P990078" ], "registration_number": [ "1211998", "3002808022", "9611516", "2247224", "3001592626", "9681121", "1932180", "8030988", "3007851054", "3008156177", "1313525", "1222616", "2031962", "3004467263", "3027683457", "3015658550", "3010220595", "3038356864", "2246552", "3010208880", "1047843", "2028159", "1000391004", "3020611964", "3009337401", "3002991496", "3029221947", "3004858034", "3016405041", "1928237", "3009462521", "1920664", "2936921", "3008252121", "9615745", "3004497289", "3002807090", "3045817901", "3013515803", "2529392", "3010849408", "3016678045", "3009026057", "3012037425", "9680671", "3009298127", "3002807715", "1018470", "8043792", "9615030", "1644019", "3005012805", "3005350457", "2939653", "1054713", "1650907", "3030860039", "8030392", "3010487482", "3007589150", "1526711", "3005941719" ], "fei_number": [ "1211998", "3002808022", "3002808269", "1000114111", "3001592626", "1720381", "3007851054", "3002807944", "3002445546", "3004467263", "3027683457", "3003465293", "3015658550", "3010220595", "3038356864", "2246552", "3010208880", "1047843", "1000391004", "3029221947", "3009337401", "3002991496", "1000125771", "3004858034", "3016405041", "3003559308", "1928237", "1920664", "2936921", "3008252121", "1000119305", "3009462521", "3004497289", "3045817901", "1000120916", "3006003617", "3001362763", "3010849408", "3016678045", "3009026057", "3012037425", "1000122089", "3009298127", "1317628", "3002807715", "1018470", "3000314405", "3003282815", "3002806902", "3005012805", "1000117501", "3002681132", "3005350457", "2939653", "1000121498", "3030860039", "3010487482", "3007589150", "3002807111", "1526711", "3002806863" ], "device_name": "Laser, Ophthalmic", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.4390", "device_class": "2" } } ] }