According to a news release, CLR Medicals initiated the recall after the U.S. Food and Drug Administration reported deficiencies in the company’s quality system. The products have been deemed a public health concern because they are being marketed without FDA approval.
The recall covers Viscocel and Viscocel Plus products manufactured from Sept. 1, 2011, to Sept. 19, 2013.
No injuries have been reported for Viscocel and Viscocel Plus, but contaminated or compromised products could cause intraocular infection, inflammation and high intraocular pressure, potentially leading to vision or eye loss.
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