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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

Product Description Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
Recall Number Z-0531-2014
Classification Class I
Code Info All lots manufactured September 01, 2011 to September 19, 2013.
Product Distributed Qty 249,592 units
Reason For Recall CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspection findings of deficiencies in the Quality System Regulations for Medical Device Manufacturers, 21 Code of Federal Regulation (CFR) Part 820 and lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce. The Viscoelastic products, intended for human and animal use, have been determined to be a possible public health concern due to distribution in the US without FDA approval, which evaluates the safety and efficacy of the product, and violations of the QSR regulations related to sterility, and biocompatibility that may result in the release of contaminated products.

Event Detail

Event Id 66930
Product Type Devices
Status Ongoing
Recalling Firm C.L.R. Medicals International, Inc.
City Pomona
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-25
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.