Company: Bausch & Lomb Incorporated Rochester, NY
Date of Enforcement Report 12/31/2014
Class lI:

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.
Recall Number Z-0864-2015

REASON
A software anomaly was identified where the system may automatically transition from “Standby” to “Ready to Fire” state while in surgical use.

RECALLING FIRM/MANUFACTURER
Bausch & Lomb Inc., Saint Louis, MO on 11/4/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
187

DISTRIBUTION
Nationwide and Internationally

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