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C.L.R. Medicals International, Inc. recalls Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to
Recalled January 1, 2014 · FDA recall Z-0531-2014 · C.L.R. Medicals International
Hazard
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 Class I
Units
249,592 units
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.
Description
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
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.
Manufacturer(s)
C.L.R. Medicals International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →