January 1, 2014Medical DevicesFDA
C.L.R. Medicals International, Inc. recalls Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to
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