Viscocel Recall Issued for Eye Solution Due to Lack of FDA Approval
Federal health officials indicate that Viscocel eye solutions may pose a public health concern, after it was discovered that the product was distributed in the United States without proper FDA approval.
A Viscocel recall was announced by the FDA on November 26, after the agency determined that the products had not been evaluated for safety or efficacy. As a result the eye solutions are in violation of quality system regulations designed to prevent the distribution of contaminated products.
Viscocel is manufactured by California-based CLR Medicals International Inc., and is used to protect eye tissue from dehydration, inflammation and the possible collapse of the cavity when diseased lenses are surgically replaced. It is part of a line of CLR products known as viscoelastics.
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In 2011, a similar product by the same company, Visco Supreme, was linked to multiple cases of endophthalmitis after it was released under similar conditions, the FDA warned. No illnesses or injuries have been linked to the Viscocel eye solutions.
Endophthalmitis causes inflammation and swelling of the eye and can lead to loss of vision and even loss of the eye itself. It is often linked to complications from eye surgery. The most common cause is bacteria and fungi, but can also be caused by penetration of the eye and by foreign bodies retained in the eye.
The recall affects all lots of Viscocel and Viscocel Plus, manufactured from September 2011 through September 19, 2013, and distributed from October 2011 through November 2013. The CLR website now has the products listed as for export only.
The company is notifying domestic distributors and is arranging for the return of recalled Viscoelastic products sold in the U.S. Customers with questions can call CLR Medicals International Inc. at (909) 398-1880.
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