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.
More Articles on Medical Recalls:
FDA Recalls Medtronic Heart Device
FDA Recalls Symbios GoPump Rapid Anesthesia System
2 Patients Who Received Recalled Meds Died
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.