FDAFDA · Food and drugs·Recall number Z-0864-2015
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.
Published December 31, 2014 · Recall initiated: November 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Bausch & Lomb Inc
- Distributor
- 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.
- Lot
- Serial numbers: SPC00747 and SPC 01918
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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