CLR Medicals International Inc. is recalling Viscocel and Viscocel Plus. This drug recall is in response to FDA 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, and violations of the QSR regulations related to sterility, and biocompatibility that may result in the release of contaminated products.
Clinical consequences that may be associated with use of the contaminated and/or adulterated products may include intraocular infection, inflammation and elevated intraocular pressure. These conditions could lead to loss of vision or even loss of the eye.
This recall includes all lots of Viscocel and Viscocel Plus, manufactured from September 01, 2011 to September 19, 2013.
No injuries have been reported to date for the Viscocel and Viscocel Plus products. However, multiple cases of endopthalmitis were reported in 2011 for the firm’s Visco Supreme, a similar product manufactured at the firm under the same conditions.