Class 1 Device Recall Viscocel and Viscocel Plus

• Date Initiated by Firm: November 25, 2013
• Date Posted: December 20, 2013
• Recall Status: Terminated on December 05, 2014
• 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 CA 91767-1922
• For Additional Information Contact: 909-398-1880
• 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: 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 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.