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U.S. Department of Health and Human Services

Class 1 Device Recall Viscocel and Viscocel Plus

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 Class 1 Recall
Viscocel and Viscocel Plus
see related information
Date Posted December 20, 2013
Recall Status1 Open
Recall Number Z-0531-2014
Recall Event ID 66930
Product Classification Aid, Surgical, Viscoelastic - Product Code LZP
Product 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.
Code Information All lots manufactured September 01, 2011 to September 19, 2013.
Recalling Firm/
Manufacturer
C.L.R. Medicals International, Inc.
748 E Bonita Ave Ste 210
Pomona, California 91767-1922
Manufacturer 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
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
Action CLR Medicals initiated a nationwide recall on November 25, 2013, of Viscocel and Viscocel Plus, by issuing a press release,in response to FDA inspectional 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 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. CLR Medicals International, Inc. sent a Medical Device Recall letter dated December 6, 2013, to all affected customers. The letter informed customers of the reason for recall, product description with manufacturing date range, possible health hazard, instructions on what to do with recalled product, and contact information for the firm and to report any adverse events to FDA MedWatch. The recall notification letter was accompanied by a response form. Customers with questions were instructed to call 909-398-1880. For questions regarding this recall call 909-398-1880.
Quantity in Commerce 249,592 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.
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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