FDA Report - FDA Public Health Advisory (Fungal Keratitis)

ReNu

Contact Lense Patients: New Information on Serious Fungal Infection Risk

April 10, 2006

Updated: April 21, 2006
Original publication date April 10, 2006

Dear Contact Lens Wearer,

This is to update you on the rare but serious eye infection in people who wear soft contact lenses. There has been a recent increase of reports in the U.S. of this infection. The infection is fungal keratitis, caused by the Fusarium fungus. It can cause a permanent loss of vision. Several patients with this infection have needed corneal transplants to save their vision.

ReNu Recall Information

On April 13, 2006, Bausch & Lomb announced a market withdrawal of all ReNu with MoistureLoc products. This means the company is removing all ReNu with MoistureLoc products off the store shelves. Bausch & Lomb is recommending that consumers stop using ReNu with MoistureLoc immediately.

Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to investigate reports of fungal keratitis to determine all contributing factors and/or products placing contact lens wearers at risk for Fusarium keratitis.

We will continue to update this notice as more information becomes available.

FDA Updated Recommendations

If you wear soft contact lenses, you should:

Stop using Bausch & Lomb ReNu with MoistureLoc products immediately and discard all remaining MoistureLoc solution including partially used or unopened bottles.
(Note: in case of a lawsuit you will need your bottles - save them)
Consult your doctor about choosing an appropriate alternative cleaning/disinfecting product.
Consider performing a "rub and rinse" lens cleaning method, rather than a no rub method, regardless of which cleaning/disinfecting solution used, in order to minimize the number of germs and reduce the chances of infection.
Continue to follow proper lens care practices:

Wash your hands with soap and water, and dry (lint-free method) them before handling your lenses.
Wear and replace your lenses according to the schedule prescribed by your doctor.
Follow instructions from your doctor and your solution manufacturer for cleaning and storing your lenses.
Keep your contact lens case clean and replace every 3-6 months.

Remove the lenses and consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.

Additional questions regarding the market withdrawal of Bausch & Lomb ReNu with MoistureLoc products contact the company at 1-888-666-2258.

If you have any concerns about your contact lenses, you should contact your doctor.

Additional information on this topic for healthcare providers can be found at:
http://www.drug-attorneys.com/fda-reports/fungal-keratitis-041006.cfm

U.S. Food and Drug Administration (FDA)

Legal Help for ReNu Consumers with Fusarium Keratitis

If you or a loved one have used, or currently use, ReNu, ReNu with MoistureLoc or ReNu MultiPlus and have been recently diagnosed with keratitis, then you may have a right to file individual legal action against Bausch & Lomb. Due to the nature of this serious infection, ReNu consumers diagnosed with keratitis are urged to contact an attorney immediately after they have been informed of their diagnosis. Many important legal issues need to be addressed after a keratitis diagnosis that can possibly affect the outcome of civil litigation. The laws and theories of liability in each state are varied and can limit the amount of time a consumer has to file a lawsuit (statute of limitations).

Confidential Medical Liability Lawsuit Case Evaluation

Each year, thousands of people die from or are seriously injured by prescription and over-the-counter drugs they believe to be safe. If you or a loved one have taken a defective drug, experienced problems with a defective medical device or used a defective product, then contact us immediately. If you or a loved one has suffered serious medical conditions or side effects, please fill out our free and confidential injury evaluation form by clicking the link below, or if you prefer, call us toll free at 1-800-883-9858 to speak with a lawyer.