Company: Bausch & Lomb Incorporated Rochester, NY
Date of Enforcement Report 12/31/2014
Class lI:
PRODUCT
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
Recall Number Z-0862-2015
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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