Z-0864-2015Class II

Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade...

Name: Z-0864-2015 Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade...
Creator: Bausch & Lomb Inc
Published: 2014-11-04
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2014-11-04 / Terminated / root cause: software

FDA source

Bausch & Lomb Inc began a recall of Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with... on 2014-11-04. FDA classified it as Class II and gives the reason as "A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0864-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-04
Posted: 2014-12-23
Terminated: 2017-03-23
Recalling firm: Bausch & Lomb Incorporated
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.
Product code: HQF Laser, Ophthalmic
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Bausch & Lomb contacted customers by phone on November 4, 2014. Customers were informed of the conditions required for the device to malfunction. Customers were also notified that a software update to address the situation will be installed in their system within the next few weeks, and that the firm's service team will be scheduling a visit to each facility to install this software update. Customers were also told that in the meantime they may continue to use the device. For further questions please call (585) 338-6839.
Quantity in commerce: 2
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, Sweden, Switzerland, Turkey and the United Arab Emirates.
Product codes and lots: Serial numbers: SPC00747 and SPC 01918

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0864-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0862-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23
Z-0863-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23
Z-0864-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23

Product code HQF

K133486Class IIStellaris Pc Vision Enhancement SystemBausch & Lomb / cleared 2014-03-12

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)