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Viscocel Eye Solution Recalled, Sold Without FDA Approval

Viscocel Eye Solution Recalled, Sold Without FDA Approval

December 2, 2013 — A Class 1 recall has been issued for Viscocel and Viscocel Plus because the eye products were sold without approval from the FDA.

The recall announcement was issued on November 26 for all Viscocel products manufactured between September 2011 – September 19, 2013 and distributed between October 2011 – November 2013. The products were not evaluated for safety or efficacy before they were sold in the U.S.

No injuries have been linked to Viscocel or Viscocel Plus. However, in 2011, multiple cases of endophthalmitis (eye inflammation and swelling) were linked to Visco Supreme, a similar product manufactured under the same conditions as Viscocel and Viscocel Plus.

Endophthalmitis is a serious inflammation of the interior coating of the eye that is caused by a bacterial or fungal infection. Most cases occur 2-5 days after eye surgery (especially cataracts surgery), though mild cases may occur weeks after surgery. Severe endophthalmitis can cause vision loss, blindness, and even loss of the entire eye.

Viscocel products were manufactured by California-based CLR Medicals International. The company advertises Viscocel as a “viscoelastic” product for use in humans and animals during eye surgery. Viscocel is designed to protect the eye tissue from dehydration during cataracts surgery.

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