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.
Need a Texas Viscocel Lawyer?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact our Texas Viscocel lawyers for a free lawsuit review.