Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 — Class II medical device recall Z-0864-2015
Terminated recall by Bausch & Lomb Inc, reported 2014-12-31, distributed in AL, CA, CT, FL, GA, HI, IL, IN…. A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fi
| Recall number | Z-0864-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb Inc, Saint Louis, MO, United States |
| Recall initiated | 2014-11-04 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2017-03-23 |
| Distributed | AL, CA, CT, FL, GA, HI, IL, IN, KS, MI, MN, MO, MS, NH, NY, OH, OK, PA, TX, WI, WV |
| Countries outside the US | AE, AT, AU, BE, CH, CN, CZ, DE, ES, FR, GB, GR, HK, HU, IE, IN, IT, JO, MA, MY, NL, NO, PT, SE, SG, TR |
| Quantity | 2 |
| Reason classes | software |
| Serial numbers | 01918, SPC00747 |
Product
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0864-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.