Bausch & Lomb’s Renu with MoistureLoc contact lens cleaning solution has been linked to a rare type of fungal eye infection called Fusarium Keratitis.Although investigations have not revealed a single, definitive causal agent at this time, the obvious correlation between product use and the Fusarium Keratitis infection has led Bausch & Lomb, the FDA and the CDC to take immediate action.
On May 15, 2006 the U.S. Food and Drug Administration issued a statement to the public alerting them to the fact that Bausch & Lomb had announced a global recall of its Renu with MoistureLoc contact lens cleaning solution.Just two days prior to this, on May 13, 2006, Bausch & Lomb suspended all United States sales of its MoistureLoc product. This was a direct response to the CDC’s announcement that it was investigating a “spike in infections in Americans using this solution.”
However, it is the Far East that first experienced fungal outbreaks in correlation with the Bausch & Lomb product. In February of 2006, sales of Renu with MoistureLoc were stopped in these countries. Infections have also occurred recently in Europe.
Ongoing federal inspections of Bausch & Lomb’s South Carolina factory in Greenville have not resulted in any evidence of sub-standard practices or contamination to date. Bausch & Lomb’s Chief Executive, Ron Zarrella, stated that “…some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances…”He also advised customers to stop using the product and emphasized that "Bausch & Lomb's top priority is the safety of our customers, and we want them to have complete confidence in our products."
What is Fusarium Keratitis?
Fusarium Keratitis is a severe, rare, painful fungal infection of the eye that can lead to blindness. Fusarium, a fungus that is found in the environment and on our skin, is generally found in plant materials in tropical and subtropical areas. Usually, Fusarium enters the eye when there is a trauma or injury to the cornea. It may also occur in individuals with compromised immune systems. It is not transmitted from person to person. It is a new phenomenon to see many otherwise healthy individuals, who have not experienced trauma to the eye, suffering from this infection.Keratitis translates to ‘inflammation of the cornea’.Diagnosis can be challenging, because the early clinical features generally present like other infections caused by viruses, bacteria and even protozoa. However, the recent surge in Fusarium Keratitis has created a heightened awareness and concern among eye doctors. The prompt recognition of an existing fungal infection is critical, as corneal scarring and permanent loss of vision can occur without immediate and appropriate treatment. Treatment consists of eye drops for a period of two to three months and sometimes an oral antifungal medication.Surgery is necessary in some cases.
Signs and Symptoms
The following is a brief list of symptoms which may be present with Fusarium Keratitis:
- Unusual redness in the eye
- Eye pain
- Blurred or hazy vision
- Excessive tearing
- Sensitivity to light
- Ocular pain
- Ocular discharge
There is a theory among some eye specialists that Renu with MoistureLoc’s properties, namely the combination of a new disinfectant called Alexidine along with newer moisturizing agents, may be contributing to the outbreak of infections.It is important to note, that although Alexidine has been determined to be safe and effective, specific conditions may change this. They are:
- Failure to routinely replace solution in lens case
- Failure to close bottle (of solution)
- Failure to effectively clean case.
Additionally, Daniel Schultz, Director of the FDA’s Center For Devices and Radiological Health said, “There does appear to be an association between the formulation itself as well as certain use patterns in creating this higher than normal incidence of these particular infections.”
On May 12, 2006, the CDC confirmed 122 cases of Fusarium Keratitis in the United States, and the majority of these cases reported using Bausch & Lomb Renu with MoistureLoc. At that time there were another 15 cases under the heading of “possible” and at least 60 more under investigation!
This troubling scenario, and the tragic damage suffered by its victims, has led many to question the efficiency and effectiveness of Bausch & Lomb’s response to the evidence as it was presented to them.Dr. Chu of NJ, a specialist in corneal diseases, phoned Bausch & Lomb back in March to alert them to the fact that three of his patients were suffering from a dangerous microbe and that all three were Bausch & Lomb customers. It has been reported that this was the first official U.S. involvement that Bausch & Lomb was aware of. Although Bausch & Lomb responded by confirmingthat there had been cases of Fusarium Keratitis in the Far East, it was Dr. Chu who first contacted the Federal Health Authorities.
There are victims in at least 32 states who are currently affected by the Fusarium Keratitis infection.Subsequently there are a growing number of lawsuits. Zoe Wade, a 69 year old woman in Florida, filed a lawsuit in Palm Beach County.She claims that she started using the Bausch & Lomb Renu with MoistureLoc solution last July. By October her infection was severe and she was in great pain.Just seven months after using the product, her doctor recommended that her left eye be removed in order to stop the infection from spreading to her brain.
Zoe Wade’s attorney also represents a 46-year old man, another Bausch & Lomb cleaning solution customer, afflicted with the fungal infection. He now has impaired vision and is suing the company.Records reveal that seven other individuals filed suits in April and seek class action status.
Barbara Cavallaro of Cranston, Rhode Island has filed a $5 million class action suit in addition to an individual suit. Her sight is permanently damaged and her eyes are now two different colors. She too, was a Renu with MoistrueLoc customer.
It is strongly urged that clinicians seeing patients with eye infections immediately refer these patients to doctors for definitive diagnoses.Clinical specimens are obtained through corneal cultures, corneal tissue biopsies or confocal microscopy.The infection may present as a gray or white lesion with a feathery border.All cases of Fusarium Keratitis should be reported to local health departments and / or the CDC.
It is extremely frightening to think that a contact lens product can lead to severe eye infection or blindness. Naturally, the rising occurrence of Fusarium Keratitis, and its association with the Bausch & Lomb cleaning solution, has many contact lens users concerned about their own safety. If you are using Bausch & Lomb Renu with MoistureLoc cleaning solution, you should discontinue immediately and throw it away. However, contact lens use is still considered a healthy choice when it is prescribed by your doctor. The American Optometric Association states that “contact lenses remain a safe and effective form of vision correction.” They do stress, however, that excellent hygiene is the key to safe contact lens use. They recommend the following guidelines to ensure safe and healthy contact lens use:
- Wash your hands with soap and water each time you handle your contact lenses.
- Clean lenses regularly.
- Lenses should be stored in a clean lens case.
- Replace your lens case every three months.
- Use the specific cleaning products recommended by your eye doctor.
- Discard old solution.
- Do not re-use old solution.
- Contact lenses need to be replaced as directed by your physician.
- If you experience symptoms such as redness, pain, tearing, or sensitivity to light, remove lenses immediately and call your doctor.
This article was originally published by www.LawsuitSearch.com on 5/21/2006 4:00 PM at http://www.lawsuitsearch.com/news/product-liability/renu_moistureloc_eye_infections_sy.aspx