Z-0863-2015 Class II Terminated
Recalled by Bausch & Lomb Inc
— Saint Louis, MO
FDA device recall Z-0863-2015 was initiated by Bausch & Lomb Inc on Nov 4, 2014 and is designated Class II. 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. The recall status is terminated (terminated Mar 23, 2017). Affected quantity: 79.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 31, 2014
- Initiation Date
- Nov 4, 2014
- Termination Date
- Mar 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79
Product Description
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 for Recall
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0863-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.