Class II — Bausch & Lomb Inc
| Recalling firm | Bausch & Lomb Incorporated |
|---|---|
| Registered facility | View this company's 10 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
| Product | 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. |
| Quantity | 79 |
| 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, Swede… |
| Initiated | 2014-11-04 |
| Classified | 2014-12-23 |
| Terminated | 2017-03-23 |
| Recall number | Z-0863-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bausch & Lomb Inc (Z-0863-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69717/
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