CLR Medicals International Inc. Viscoelastic Products: Recall - Quality System Deficiencies And Lack Of Premarket Approval (PMR)
AUDIENCE: Risk Management, Health Professional
ISSUE: 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. 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.
Recalled Viscoelastic products were manufactured from September, 2011 through September 19, 2013 and distributed from October 2011 through November 2013. This recall includes all lots of Viscocel and Viscocel Plus, manufactured from September 01, 2011 to September 19, 2013.
BACKGROUND: 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.
RECOMMENDATION: 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. For more information, health professionals and consumers should contact CLR Medicals International Inc. between the hours of 9AM – 6PM Pacific Time, Monday - Friday.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[11/25/2013 - Press Release - CLR Medicals International]