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U.S. Department of Health and Human Services

Class 2 Device Recall MLS Torpedo MiniLight Ophthalmic singleport illumination

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 Class 2 Recall
MLS Torpedo MiniLight Ophthalmic singleport illumination
see related information
Date Posted November 04, 2013
Recall Status1 Open
Recall Number Z-0144-2014
Recall Event ID 66040
Product Classification Punch, Corneo-Scleral - Product Code HNJ
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.
Code Information Part Number Lot Number Expiration 11007 M52934 04/2013 11017 M53017 04/2013 11007 M55285 07/2013 11007 M55869 08/2013 11007 M58610 12/2013 11007 M59575 02/2014 11007 M61781 05/2014
Recalling Firm/
Manufacturer
Insight Instruments, Inc.
2580 Se Willoughby Blvd
Stuart, Florida 34994-4701
For Additional Information Contact Ross McDonough
727-219-9393
Manufacturer 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.
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
Action Insight Instruments, Inc. sent a letter dated April 8, 2013, via USPS priority mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue using and dispensing all affected product, perform a physical count of their inventory and complete the Return Response Form and fax to 772-219-9342. Customers were also instructed to call 800-255-8354 to arrange for return and prompt reimbursement. For questions regarding this recall call 727-219-9393.
Quantity in Commerce 10212
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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