On May 15, 2006, the United States. Food and Drug Administration announced that Bausch & Lomb, makers of ReNu with MoistureLoc, a contact lens cleaning solution that had been linked to nearly three dozen confirmed cases of Fusarium keratitis in the United States, had recalled the product worldwide.

Due to the suspicious number of complaints and adverse event reports received by FDA and the Centers for Disease Control, FDA conducted an investigation of the Bausch & Lomb production facility in Greenville, South Carolina. In its preliminary findings, FDA identified 20 potential violations at the Greenville facility, including Bausch & Lomb's failure to report to FDA or CDC a prior outbreak of 25 cases of Fusarium keratitis in Asia that had been linked to use of ReNu with MoistureLoc. Reports have revealed that Bausch & Lomb received reports of such problems as early as July 2005 but did not report the details of those outbreaks to the FDA as required by federal law.

The eye infection reported in these cases is a rare but extremely virulent microbial keratitis caused by the fungus Fusarium. The infection may cause serious personal injuries, including corneal damage so severe that it can ultimately 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, 2006, over 200 cases of fungal keratitis had been reported to FDA or CDC, with 73 of those cases traced to ReNu with Moisture Loc. Based on these and other data, researchers at the Centers for Disease Control and Prevention, determined in August that ReNu with MoistureLoc is the only contact lens cleaning solution known to have contributed to fungal keratitis in contact lens wearers. Instances of personal injury related to fungal keratitis have been reported in 33 different states. Over 1/3 of the 164 contact lens wearers with confirmed cases of fungal keratitis have required corneal transplants.

CDC Recommendations for Contact Lens Wearers:

• Stop using Bausch & Lomb ReNu with MoistureLoc products.
• Consult your eye care professional concerning use of 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 hands with soap and water, and dry (lint-free method) before handling lenses.
   
• Wear and replace lenses according to the schedule prescribed by your doctor.
   
• Follow the specific lens cleaning and storage guidelines from your doctor and the solution manufacturer.
   
• Keep the 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.
   

What is Fusarium Keratitis?

Keratitis is an inflammation of the cornea, the front part of the eye. Keratitis has many causes including bacteria, viruses and fungi. CDC is currently investigating reports of keratitis caused by Fusarium, a type of fungus.

While Fusarium keratitis can be a serious infection, it is a rare disease. Fusarium is commonly found in organic matter such as soil and plants. This infection cannot be transmitted from person to person. People who have trauma to the eye, certain eye diseases and problems with their immune system may be at increased risk for these types of infection.

Fusarium keratitis can result in severe corneal damage, and even total vision loss. Many people suffering from this condition are ultimately confronted with the unwelcome prospect of a full corneal transplant.

Symptoms of Fusarium Keratitis

The symptoms of Fusarium keratitis include sudden blurred or fuzzy vision, red and irritated eyes lasting for an unusually long period of time, pain in and around the eyes, increased sensitivity to light and excessive eye tearing. If you experience these symptoms you should contact your optometrist or ophthalmologist immediately.

Should I Consult an Attorney Regarding my Eye Infection Injury Case?

The Wall Street Journal reported on April 27, 2005, that Chinese health officials had alerted Bausch & Lomb as early as November 2005 to a problem with its Renu with MoistureLoc product. Hong Kong health officials also recognized an increase in hospital admissions for people 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. Bausch & Lomb reported these cases to FDA, but its report stated that there was no evidence linking use of its product to the infections. Despite this alarming outbreak in Asia, Bausch & Lomb made no public statements about the infections. FDA later announced that Bausch & Lomb failed to report to FDA or CDC that 35 cases of fusarium keratitis in Singapore were confirmed as being linked to use of the Renu with MoistureLoc product in violation of applicable federal regulations. A Bausch & Lomb plant in Greenville, South Carolina has been directly linked to a number of fungal keratitis infections (See FDA Statement on Preliminary Bausch & Lomb Inspection Findings, May 16, 2006).

If you have been diagnosed with fungal keratitis and used ReNu with Moisture Loc contact lens solution within four to six weeks prior to your diagnosis, you should consider speaking with one of our attorneys regarding the rights and remedies that are available to you. While FDA may pursue administrative enforcement action against Bausch & Lomb, consumers who have been harmed by the Renu with MoistureLoc product must pursue their own remedies through the legal system, where courts and juries will determine whether Bausch & Lomb is liable for damages.

Given the amount of money at issue in this litigation, consumers owe it to themselves to hire attorneys who have the knowledge, experience and tenacity to take on big companies like Bausch & Lomb in the courtroom. At JMP, our lawyers once worked for corporations like Bausch & Lomb. We know how they work. We know the tricks they will employ in attempting to escape responsibility for their actions. We love nothing more than seeking the truth, and will do everything in our power to hold responsible defendants accountable for their negligence.


If you or a loved one is suffering from fungal infections like fusarium keratitis, and believe that the condition may be linked to use of Renu with MoistureLoc, please contact

John Jensen
Mark McGrath
George Podgorny, Jr.

Jensen McGrath Podgorny, PA
www.JMPAttorneys.com
Info@JMPAttorneys.com

430 Davis Drive, Suite 250

Research Triangle Park, NC 27709

(919) 433-4480 (tel.)

(919) 433-4485 (fax)