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Insight Instruments, Inc. recalls MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surge
Recalled November 13, 2013 · FDA recall Z-0144-2014 · Insight Instruments
Hazard
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. · FDA Class II
Units
10212
Sold at
Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey.
Description
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.
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.
Manufacturer(s)
Insight Instruments, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →