Recall Z-0144-2014— Insight Instruments, Inc.

Name: FDA recall Z-0144-2014
Creator: U.S. Food and Drug Administration
Published: 2013-06-27

Class II · Terminated

Class II FDA medical device recall by Insight Instruments, Inc., initiated 2013-06-27, terminated 2017-09-27. FDA's recall record names no specific 510(k) clearance for this event. Product: MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.. Reason: The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance..

Recalling firm: Insight Instruments, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-27
Terminated: 2017-09-27
Firm location: Stuart, FL, United States

Product description

MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.

Reason for recall

The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.

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