BL14334 Cl II Bausch & Lomb Stellaris PC w/ Laser

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

___________________________________

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.