Recall Z-0593-2013— Bausch & Lomb Inc

Name: FDA recall Z-0593-2013
Creator: U.S. Food and Drug Administration
Published: 2012-08-31

Class II · Terminated

Class II FDA medical device recall by Bausch & Lomb Inc, initiated 2012-08-31, terminated 2013-07-11. It names one FDA 510(k) clearance: K101325. Product: Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.. Reason: Posterior fluidics modules installed in the system may need to be recalibrated..

Recalling firm: Bausch & Lomb Inc
Classification: Class II
Status: Terminated
Initiated: 2012-08-31
Terminated: 2013-07-11
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K101325 — STELLARIS PC VISION ENHANCEMENT SYSTEMBausch & Lomb, Inc.·cleared 2010-08-17

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 Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.

Reason for recall

Posterior fluidics modules installed in the system may need to be recalibrated.

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