Bausch and Lomb Issues Public Letter Regarding ReNu and Contact Lens Solution Infection

Users offered full refund or free replacement with other B&L contact lens products.

Eye care company issues recall regarding possible link with infection and ReNu with MoistureLoc contact lens solution.

Does ReNu with MoistureLoc cause Fusarium keratitis?

We’ve conducted extensive testing, analysis and further internal and expert review, and the available scientific evidence does not establish ReNu with MoistureLoc as the cause. However, data released by the Centers for Disease Control and Prevention identified a disproportionate association of a small number of events with ReNu with MoistureLoc manufactured in the U.S. As such, we are working with the FDA, the CDC and leading experts to try to identify if there is a causal relationship.

What is a Fusarium infection?

Fusarium is a fungus commonly found throughout our everyday environment, including on our skin. It especially thrives in tropical climates. Fusarium typically enters the eye through some sort of trauma or injury to the cornea, resulting in an inflammatory reaction. The situation can be treated with combinations of anti-fungal and anti-inflammatory medications. The infection is serious, and the earlier treatment is started, the better the results will be. Should I continue to use the ReNu with MoistureLoc I have at home?

Until we get the answer to what’s causing these infections, we recommend you don’t use ReNu with MoistureLoc manufactured at our U.S. plant, and switch to another product such as Renu MultiPlus, which has been relied on by contact lens wearers for years, the original ReNu Multi-Purpose solution, or to another respected brand. You should always follow the advice of your Eye Care Professional and the directions on the lens care products of your choice. Proper care and cleaning of your contact lenses is the key to healthy contact lens wear.

Why does this only affect ReNu with MoistureLoc that’s made in the United States?

Because the places where an apparent increase in Fusarium infections among contact lens wearers has been reported — three countries in Asia and here in the U.S. — are all served from the U.S. plant. In other markets — Europe, China and India, for example — the product is made in other factories, and there have been no unusual trends in Fusarium infections reported.

What can I do to prevent getting a Fusarium infection?

You should wash your hands with soap and water and dry them before handling your lenses, wear lenses according to the schedule prescribed by your Eye Care Professional and follow guidelines for cleaning and storing lenses provided by your Eye Care Professional and solution manufacturers. If you have questions about which solution is best for you, consult your Eye Care Professional. Can I return the ReNu with MoistureLoc I have at home?

Visit www.bausch.com/renu or call 1-888-666-2258 to arrange to receive a free coupon (up to $8) for Renu MultiPlus or original Renu Multi-Purpose solution, or a form to return your bottle of ReNu with MoistureLoc (U.S. only) and request a refund.

Dear Loyal ReNu Consumer,

For more than 150 years, Bausch & Lomb’s mission has been to enhance your vision. Our highest priority is protecting the health and safety of your eyes.

I am writing this letter because we find ourselves in a position where the safety of one of our products, ReNu® with MoistureLoc,® manufactured at our United States plant, is in question. And that most certainly raises questions for you. I apologize for the confusion of the past few days and will try to clear up what I can.

When reports of a rare eye infection, seemingly associated with our product, began to surface, we began a series of exhaustive tests on our products, and a thorough inspection of our U.S. plant. Nothing has yet been found to show that ReNu with MoistureLoc contributed to these infections in any way.

However, because the health and safety of your eyes will always be our first priority, we’ve stopped shipments of ReNu with MoistureLoc from the U.S. plant, and are asking retailers to take the products off the shelves until the investigation is concluded. We also recommend that you discontinue using ReNu with MoistureLoc for the time being and switch to another product such as ReNu® MultiPlus,® which has been relied on by contact lens wearers for years, the original ReNu® Multi-Purpose solution, or to another respected brand.

We continue to work tirelessly with the Food and Drug Administration, the Centers for Disease Control and Prevention, the Johns Hopkins Wilmer Eye Institute, major eye centers and experts around the world to identify the cause of this infection. We won’t stop until we’re finished. If there is a problem with our product, we’ll find it and we’ll fix it. If there’s not, when we come back you’ll be able to know with absolute certainty that we’ve taken every possible step to ensure your safety.

To help you better understand how this may affect you, you’ll find below the answers to the most frequent questions that our Help Center has been receiving. If you have other questions, please see your Eye Care Professional, visit our website www.bausch.com or call our Help Center at 1-888-666-2258. We will continue to provide you with updates until this situation is resolved.

Finally, I strongly encourage you to strictly follow the contact lens wear and care recommendations of your Eye Care Professional to be sure you can continue to enjoy safe and comfortable contact lens wear.

I am sorry for any inconvenience or anxiety this situation has caused. We appreciate your loyalty to Bausch & Lomb.

We value your trust and remain committed to earning it every day.

Sincerely,
Ron Zarrella
Chairman
Bausch & Lomb

Tags: bausch & lomb, recall, renu, contact lens, fungus, fusarium, keratitis, USAEyes, eye