Recall Z-0863-2015 ยท HQF Laser, Ophthalmic
Bausch & Lomb Inc
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.
| Date | Dec 23, 2014 (initiated Nov 4, 2014) |
| 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. |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133486 | STELLARIS PC VISION ENHANCEMENT SYSTEM Bausch & Lomb, Mar 12, 2014 |