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U.S. Department of Health and Human Services

Class 2 Device Recall Insight Instruments MIS ( MultiPort Illumination System)

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 Class 2 Device Recall Insight Instruments MIS ( MultiPort Illumination System)see related information
Date Initiated by FirmMarch 15, 2013
Date PostedMay 10, 2013
Recall Status1 Terminated 3 on August 21, 2014
Recall NumberZ-1281-2013
Recall Event ID 64887
Product Classification Cannula, Ophthalmic - Product Code HMX
Product Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.
Code Information Lot Numbers: M53157, M55115, M56929, M58551, M61862.
Recalling Firm/
Manufacturer		 Insight Instruments, Inc.
2580 Se Willoughby Blvd
Stuart FL 34994-4701
For Additional Information ContactRoss McDonough
727-223-2733
Manufacturer Reason
for Recall		Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.
FDA Determined
Cause 2		Use error
ActionInsight Instruments, Inc. sent a recall letter dated March 15, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to do the following: 1)Perform a physical count of their inventory immediately for any of the recalled lots and complete and return the Return Response Form. 2) If they have any products listed, contact the firm at (800) 255-8354, to arrange for return and prompt replacement. 3) Discontinue using and dispensing all M.I.S. devices of the recalled lots.
Quantity in Commerce776
DistributionUS Distribution IN and IL
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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