ReNu with MoistureLoc linked to potentially blinding eye infection Fusarium Keratitis

In April 2006, eye care company Bausch & Lomb suspended sales of its ReNu with MoistureLoc contact lens solution after health officials linked the product to a serious fungal infection of the eye - fusarium keratitis. According to the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention, investigators are reviewing reports of 109 cases of suspected Fusarium keratitis in people in 17 states since June 2005. Although only 30 of those patients have been interviewed, 26 of the 28 who wore soft contact lenses reported using ReNu brand products. Eight patients had to undergo corneal transplants.

In May 2006, Bausch & Lomb announced that cases of Fusarium keratitis had been reported by ReNu users in Europe, the first time the company acknowledged European cases since the news of the fungus went public. The Centers for Disease Control and Prevention also stated that over a dozen people diagnosed with the fungus had used a different ReNu product, ReNu Multiplus, which the company is still selling. In at least six separate cases, according to the CDC, people used solutions from two other companies.

On May 15th, 2006, Bausch & Lomb announced that they would permanently withdraw ReNu with MoistureLoc.  The new-formula contact-lens cleaner viewed as the "potential root cause" of a far-flung outbreak of fungal eye infections known to cause blindness. The Food and Drug Administration has reported that the eye-care company thinks ReNu with MoistureLoc's unique disinfecting and moisturizing agents "in certain unusual circumstances can increase the risk" of developing Fusarium keratitis.

If you have suffered an eye injury while using the Baush and Lomb products, you may have a claim. Contact our experienced ReNu Recall Attorneys.

In Depth Information: ReNu with MoistureLoc Recall

The Centers for Disease Control and Prevention on May 9, 2006 said it has confirmed 106 cases of serious eye infection that may be linked to contact lens use.

The CDC said that throughout the investigation, the proportion of patients who reported using Bausch & Lomb Inc.'s ReNu with MoistureLoc has remained relatively consistent, at around 50% to 60% of confirmed cases. Of the 98 confirmed cases of which the CDC has complete data, 66% reported using ReNu with MoistureLoc, while 21% said they used Bausch & Lomb's ReNu MultiPlus product.

Eye-care products maker Bausch & Lomb Inc. halted U.S. sales of its ReNu with MoistureLoc solution on April 10 when the Centers for Disease Control and Prevention revealed it was investigating a flurry of Fusarium keratitis infections in Americans using the product.

The proportion of patients who said they used MoistureLoc has since held steady at around 50 percent to 60 percent of the 102 cases confirmed so far, the CDC said. Other patients have reported using other ReNu brands and six said they used cleaners made by Alcon Inc. and Advanced Medical Optics Inc., it said.

"At this point, it is too early in the investigation to say whether a particular product or solution may be responsible for the outbreak," the Atlanta-based agency said in a statement.

The agency has received a total of 195 reports of eye infections caused by Fusarium keratitis of which 12 are "possible cases" and 81 were still under investigation. On Tuesday, the CDC said it had received 191 reports, including 86 confirmed cases.

Fifty-six of the confirmed cases involved contact-lens wearers, with 32 of them saying they used MoistureLoc, 15 saying they used ReNu MultiPlus and seven an unspecified ReNu product. In some cases, patients reporting using more than one type of lens cleaner.

Without eye-drop treatment, the infection can scar the cornea and blind its victims. At least eight patients have required cornea transplants. Because it's not a disease that doctors must report, it is unclear how many cases occur annually.

Of the more than 30 million Americans who wear contact lenses, about 2.3 million of them use MoistureLoc and nearly 11 million use MultiPlus.

MoistureLoc first hit store shelves in late 2004 and contains new-generation moisturizing and conditioning agents. It generated $45 million in U.S. sales last year.

What is a Fusarium infection?

Fusarium is a fungus commonly found throughout our environment, including on our skin. It grows in tropical climates. Fusarium usually enters the eye through some sort of trauma or injury to the cornea, resulting in an inflammatory reaction. The infection is generally aggressively treated with combinations of anti-fungal and anti-inflammatory medications. The earlier the infection is diagnosed and treatment is commenced, the better the prognosis.

What are the symptoms of Fusarium Keratitis?

Symptoms include blurred vision, a red and painful eye that does not improve when the contact lens is removed, increased sensitivity to light, and excessive tearing or discharge. If you experience any of these symptoms, you should return to your optometrist immediately.

How can you get fungal keratitis?

Risk factors for fungal keratitis include trauma (usually where plant material gets into the eye), chronic or ongoing disease of the surface of the eye and compromised immune systems.  It is unusual under normal circumstances for it to be caused by contact lens use. Keratitis is not transmitted from person to person.

Since June 2005, there has been a marked increase in Fusarium keratitis infections, primarily among contact lens wearers. The U.S. Food and Drug Administration (FDA) and U.S. Centers for Disease Control and Prevention (CDC) are investigating possible causes for this jump in infections.

How is Fusarium keratitis treated?

Fusarium keratitis is treated using topical and oral antifungal medications. Patients who do not respond to medical treatment may require eye surgery, including possible need for corneal transplant.

What can I do to prevent getting a Fusarium infection?

The CDC recommends the following:

Contact lens users should wash their hands with soap and water and dry them before handling lenses, wear lenses according to the schedule prescribed by eye care practitioners and solution manufacturers and follow guidelines for cleaning and storing lenses provided by eye care practitioners and solution manufacturers. Contact lens users with questions about which solutions are best for them should consult their eye care professionals and carefully weigh risks and benefits.

Should consumers continue to use ReNu with MoistureLoc?

Consumers should strictly follow the advice of their eye doctors and the directions on the lens care products of their choice. Compliance with good lens wear and care practices is key to healthy contact lens wear.

Should ReNu with MoistureLoc users switch to another product?

Consumers should consult with their eye doctors and the directions on the lens care products of their choice. Compliance with good lens wear and care practices is key to healthy contact lens wear.

What is Bausch & Lomb doing to investigate the reported cases of the Fusarium fungus linked to ReNu with MoistureLoc?

Bausch & Lomb is working with the CDC and the FDA to determine the actual incidence and cause of the infections. They have temporarily suspended U.S. shipments of ReNu with MoistureLoc because the numerical analysis of a small number of cases indicates most patients used that product. At this time the suspension does not affect other products or other markets.

What should I do if I think I have an eye infection from using a Baush and Lomb product?

If you believe you may have an eye infection or have other concerns about your eyes, you should see an ophthalmologist immediately. If you have suffered an eye injury while using the Baush and Lomb products, you may have a claim. Contact an experienced ReNu Recall Attorney for a case evaluation.

In the News: Bausch & Lomb ReNu Recall

05-18-06: Bausch & Lomb Defends Response to Infections

Bausch & Lomb Inc. said it began discussions with U.S. health regulators within days of receiving reports in February of an unusual incidence of severe fungal infections among contact lens wearers in Singapore.

05-15-06: Bausch & Lomb Could Face Class Action Suit Over Lens Solution

Of the more than 30 million Americans who wear contact lenses, about 2.3 million use MoistureLoc, which accounted for $100 million in global sales last year. http://www.cbsnews.com/...

05-15-06: Bausch & Lomb Permanently Removes MoistureLoc Cleaner

Bausch & Lomb is removing its Renu with MoistureLoc contact lens cleaner from all markets around the world, saying the solution's formula may increase the risk of a potentially blinding infection. http://www.bloomberg.com/...

05-15-06: Bausch & Lomb Pulls Lens Solution

Bausch & Lomb Inc. has permanently withdrawn a new-formula contact-lens cleaner viewed as the "potential root cause" of a far-flung outbreak of fungal eye infections known to cause blindness.

05-10-06: More infections are tied to Bausch contact cleaner

An update from U.S. government health officials on the outbreak of a potentially blinding fungal infection among contact lens users showed a sharp rise in the number of cases in users of the ReNu brand of lens cleaners made at Bausch & Lomb's factory in Greenville, South Carolina. http://www.iht.com/...

05-10-06: Lens cleaner linked to most eye fungus cases

Nearly two-thirds of contact-lens wearers who contracted a potentially blinding fungal eye infection reported using Bausch & Lomb Inc.'s newest lens cleaner, health authorities said Tuesday. http://www.chicagotribune.com/...

05-10-06: CDC confirms additional eye infections: High percentage Bausch & Lomb users infected

The Centers for Disease Control said Tuesday it has confirmed additional U.S. cases of a rare eye infection called fusarium keratitis, with an unusually high percentage of the cases being reported by users of Bausch & Lomb contact lens solution products. http://www.cnn.com/...

05-10-06: Eye fungus: Rare but there

The eye fungus recently reported among contact wearers is so rare that Richard Weiss, a doctor with Michiana Eye Center, Mishawaka, has seen only two cases of it in 26 years of practice. One of the cases, though, has been within the past several weeks. http://www.southbendtribune.com/...

05-10-06: Eye Infection Remains A Mystery

Health officials still do not know what caused a rare fungal eye infection. However, more than half of the people with the infection say they've used a contact lens cleaner by Bausch and Lomb. http://www.allheadlinenews.com/...

05-07-06: FDA Not Ready To Order Recall Of Bausch & Lomb ReNu

Though suspicion continues to mount that Bausch & Lomb's ReNu products are behind an outbreak of a rare but serious eye infection, the FDA says it has not concluded there is enough evidence to initiate a recall. http://www.consumeraffairs.com/...

05-05-06: FDA News: Update on Serious Eye Infections Associated With Soft Contact Lens Use and Contact Lens Solution

Patients with confirmed cases of Fusarium keratitis have reported using various contact lens cleaning solutions including various types of ReNu products and generics.