FDA Device recall Z-0863-2015

Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhance…

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 BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhance… 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-0863-2015
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 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

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: SPC00146, SPC00148, SPC00181, SPC00362, SPC00384, SPC00393, SPC00403, SPC00406, SPC00418, SPC00422, S… 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

code_info

Serial numbers: SPC00146, SPC00148, SPC00181, SPC00362, SPC00384, SPC00393, SPC00403, SPC00406, SPC00418, SPC00422, S…

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

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-0863-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.