Fungal Keratitis Linked to Bausch & Lomb ReNu Contact Lens Solution

The U.S. Food and Drug Administration (FDA) released a statement on Monday, May 15, 2006 announcing that Bausch & Lomb, makers of the ReNu with MoistureLoc contact lens cleaning solution product that has been linked to at least 32 confirmed cases of Fusarium keratitis infection in the United States, had recalled the product worldwide.

Due to an alarming number of adverse event reports received by the FDA and the Centers for Disease Control (CDC), the FDA investigated a Bausch & Lomb facility in Greenville, SC, linked to cases of a fungal eye infection known as Fusarium keratitis, a rare bacterial infection, in the U.S., Singapore and Hong Kong. In its preliminary statement on its investigation, the FDA found 20 potential violations in the Greenville, SC, facility. Among the most serious findings in the report was the fact Bausch & Lomb did not report to the FDA or the CDC that 35 cases of Fusarium keratitis in Singapore were confirmed as being linked to their product within 35 days as required for products manufactured in the United States. The company had reports of problems as early as July 2005 but had not reported details to the FDA as of May 9, 2006.

The eye infection reported in these cases, a rare but extremely serious microbial keratitis caused by the fungus Fusarium, may cause personal injury and vision loss severe enough to require corneal transplants in affected individuals. Fusarium keratitis requires up to three months of treatment and may cause corneal scarring and permanent blindness.

As of April 27, over 200 cases of fungal keratitis have been reported to these federal agencies, with 73 of them traced to a product manufactured by Bausch & Lomb: ReNu with Moisture Loc, a contact lens cleaning solution. As of May 15, 2006 122 cases of Fusarium keratitis have been confirmed in the U.S., and healthcare researchers, including doctors at the Centers for Disease Control and Prevention, determined in August that ReNu with MoistureLoc cleaning solution is the only contact lens product known to have contributed to eye infections in contact lens wearers. Instances of personal injury related to fungal keratitis have been reported in 33 different states, and over one-third of the 164 contact lens wearers with confirmed cases of fungal keratitis required corneal transplantation to recover their eyesight.

Do I Need a Personal Injury Lawyer for my Eye Infection Injury Case?

The Wall Street Journal reported on April 27, 2005, that Bausch & Lomb, maker of the ReNu Moisture Loc contact lens solution, was alerted by Chinese health officials as early as last November to a problem with its product but did not alert consumers. Hong Kong health officials recognized a rising number of people admitted to hospitals with contact-lens related keratitis between June and September of 2005. Seven of those cases were linked to Bausch & Lomb's ReNu Moisture Loc product. The company reported those cases to the FDA, but the company's report stated there was no evidence that ReNu Moisture Loc caused the infections. Bausch & Lomb made no public statements about the infections. The FDA later announced that Bausch & Lomb did not report to the FDA or the CDC that 35 cases of Fusarium keratitis in Singapore were confirmed as being linked to their product within 35 days as required for products manufactured in the United States. The company had reports of problems in Singapore as early as July 2005 but had not reported details to the FDA as of May 9, 2006.

A Bausch & Lomb plant in Greenville, SC, has been traced to fungal keratitis infections in personal injury victims (Source: FDA Statement on Preliminary Bausch & Lomb Inspection Findings, May 16, 2006). Several class action lawsuits have been filed against Bausch & Lomb alleging liability in patient's infections. If you have been diagnosed with fungal keratitis and have used ReNu Moisture Loc contact lens solution within four to six weeks prior to your diagnosis, you should consider speaking with a personal injury lawyer about the product liability laws that may apply to your case.

The FDA may still take enforcement action against Bausch & Lomb, such as issuing a warning letter about manufacturing violations or seizing products, but consumers who have been harmed by products must pursue remedies through the legal system, where the courts will determine whether Bausch & Lomb is liable for damages. There is never any obligation to hire our firm. Your first conversation with us will not cost you. Contact us today or give us a call right now at 800-220-7321.