Recall Z-0862-2015— Bausch & Lomb Inc

Name: FDA recall Z-0862-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-04

Class II · Terminated

Class II FDA medical device recall by Bausch & Lomb Inc, initiated 2014-11-04, terminated 2017-03-23. It names one FDA 510(k) clearance: K133486. Product: Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY. 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: Bausch & Lomb Inc
Classification: Class II
Status: Terminated
Initiated: 2014-11-04
Terminated: 2017-03-23
Firm location: Saint Louis, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K133486 — STELLARIS PC VISION ENHANCEMENT SYSTEMBausch & Lomb·cleared 2014-03-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.