Recall Z-1554-2014— Bausch & Lomb Inc- Greenville Solutions Plant

Name: FDA recall Z-1554-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-21

Class II · Terminated

Class II FDA medical device recall by Bausch & Lomb Inc- Greenville Solutions Plant, initiated 2014-04-21, terminated 2015-01-09. It names one FDA 510(k) clearance: K083757. Product: Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.. Reason: Out of specification results for one of the two disinfectants..

Recalling firm: Bausch & Lomb Inc- Greenville Solutions Plant
Classification: Class II
Status: Terminated
Initiated: 2014-04-21
Terminated: 2015-01-09
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K083757 — BPZ02 MULTIPURPOSE SOLUTIONBausch & Lomb, Inc.·cleared 2009-11-18

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, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.

Reason for recall

Out of specification results for one of the two disinfectants.

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