Viscocel Eye Solution Recalled, Sold Without FDA Approval

December 2, 2013 — The U.S. Food and Drug Administration (FDA) announced a Class 1 recall of Viscocel and Viscocel Plus because they were sold without FDA approval.

Although no injuries have been reported, multiple cases of endophthalmitis were reported in 2011 for Visco Supreme, which is a similar product that was manufactured under the same conditions as Viscocel and Viscocel Plus.

Endophthalmitis is an inflammatory condition of the interior of the eye that is caused by an infection with bacteria or fungi. Most cases occur after eye surgery, particularly cataract surgery (within 2-5 days, but up to several weeks after surgery). Severe cases may cause blindness and even loss of the eye itself.

The FDA announced the recall on November 26 after finding that Viscocel products had not been evaluated for safety or efficacy, in violation of federal law. Products included in the recall were manufactured from September 2011 through September 19, 2013 and distributed from October 2011 through November 2013. The recall includes all lots of Viscocel and Viscocel Plus.

Viscocel is manufactured by CLR Medicals International, a California-based company. The product is used on humans and animals to protect eye tissue from during cataracts surgery, in which diseased lenses are surgically removed and replaced. The line of products is called viscoelastics.

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