FDA Device recall Z-0864-2015
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhanc…
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhanc… by Bausch And Lomb, citing A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0864-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-04 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bausch And Lomb |
| Distribution | AL, CA, CT, FL, GA, HI, IL, IN, KS, MI, MN, MO, MS, NH, NY, OH, OK, PA, TX, WI, WV |
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
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Identifiers
| code_info | Serial numbers: SPC00747 and SPC 01918 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0864-2015%22
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