Silver Spring, Maryland–(ENEWSPF)–November 25, 2013. CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, 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.
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. Adverse reactions or quality problems experienced with the use of this product may be reported to CLR Medicals International Inc. at the contact number listed above and FDA MedWatch:
- Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or call FDA 1-800-FDA-1088
Recalled Viscoelastic products were manufactured from September, 2011 through September 19, 2013 and distributed from October 2011 through November 2013. This recall is being conducted in accordance with the labeled shelf life of the product and any expired product should be discarded.
CLR Medicals International Inc. is notifying its domestic distributors by direct mail, email or telephone and is arranging for the return of recalled Viscoelastic products. Please contact CLR Medicals International Inc. between the hours of 9AM – 6PM Pacific Time, Monday – Friday.
CLR Medicals International Inc.
748 E. Bonita Ave, Suite 210,
Pomona, CA, 91767
This product is manufactured by CLR Medicals International Inc., who is managing the recall activities. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration
Recalled Product Photos Are Also Available on FDA’s Flickr Photostream.