Bausch Lomb Recall
The well-known contact lens supply manufacturer, Bausch & Lomb has recently issued a world-wide recall of its ReNu with MoistureLoc contact solution. The recall resulted from findings by the FDA of a sharp increase in the number of fungal eye infections in the US and worldwide. As of May 18, the CDC has received reports of 130 confirmed cases of Fusarium keratitis. Among those cases, 125 wore contact lenses, and 118 could identify which contact lens solution(s) they used.
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Seventy-five (64%) reported using ReNu with MoistureLoc along fourteen (12%) reported using MoistureLoc in combination with another product, eight (7%) reported using an unspecified Bausch & Lomb solution, and 21 (18%) reported using only products other than MoistureLoc, from various manufacturers. While not all reported cases of fungal eye infection resulted from use of ReNu with MoistureLoc, the number of individuals who used ReNu with MoistureLoc and suffered fungal eye infections were disproportionately high. Since fungal infections among normal contact lens wearers is not a common occurrence, the high incidents of reported infections in the US and worldwide gave cause for alarm.
Bausch & Lomb first stopped shipment of its ReNu with MoistureLoc product on April 10, 2006 after the FDA issued a warning indicating an increase in fungal eye infections. On May 15, 2006, a recall of all its solutions was issued, asking retail stores to pull the product from their shelves. Bausch & Lomb also issued a statement asking customers to stop use of ReNu with MoistureLoc and switch contact solutions. While Bausch & Lomb has stated that they will not reintroduce ReNu with MoistureLoc, they have made it clear that none of their other eye care products have been affected. Bausch & Lomb’s other contact lens care products, such as ReNu MultiPlus, use a completely different formulation, and have had a long history of being extremely safe and effective. A new program, Wear & Care, has been launched by the company in an effort to provide information and products to consumers to help maintain eye health.
Findings have shown that the fungal infection is caused by Fusarium keratitis, an organism that is usually found in plant and soil material in tropical and subtropical regions. At first, contamination of the contact solution was suspected, but recent testing has confirmed that the culprit is not contamination, but the formula itself. Inspection of the company’s Greenville, South Carolina plant did reveal 20 FDA health and safety violations, though none of these violations can be directly linked to the fungal outbreak. Preliminary results to date from testing of environmental factors, raw materials, in-line manufacturing processes and finished products have not found that these factors have contributed to Fusarium contamination. Investigations have also ruled out the possibility of a counterfeit product or product tampering. The most serious violations Bausch & Lomb has been charged with so far are its failure to notify authorities of Fusarium cases at first, and its failure to recall the product in Asia, where large numbers of cases were first reported.
Because of the formulation of the contact solution, which contains three polymers, specifically of a substance called alexidine, instead of the usual one, the fungus is protected from the disinfectant that would otherwise kill it. The polymers were originally added to the solution to increase comfort for the contact lens wearer. Since the fungus is protected, with each use of the contact solution, it would continue to grow. Infection by Fusarium keratitis affects the cornea, which is the clear, round dome covering the eye’s iris and pupil. It is usually a rare infection, but it is very serious, and if left untreated, can cause blindness. Typically, infection by Fusarium keratitis is caused by trauma of the eye (where plant material gets into the eye), chronic or ongoing disease of the surface of the eye, or compromised immune systems. It is not transmitted from person to person.
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Symptoms of fungal infection of the eye by Fusarium keratitis include eye pain, eye discomfort, a decrease in vision, excessive discharge, and light hypersensitivity. Sometimes, the infection may appear as a grayish-white lesion with feathery borders. Because many optometrists and ophthalmologists have never seen this type of infection, they are ill equipped to diagnose it. Instead, it is misdiagnosed as a bacterial infection, pink eye, or conjunctivitis. Treatments for these conditions are ineffective against Fusarium keratitis. Since it is often difficult to differentiate between a bacterial and a fungal infection, confirmation may be obtained through a corneal culture, corneal tissue biopsy, or confocal microscopy.
Proper diagnosis and treatment are critical to combat an infection by Fusarium keratitis. If left untreated, the infection can affect the entire cornea, and result in blindness. Treatments include prolonged drug therapy with topical or oral anti-fungals. If these do not work, surgery is required to remove the infection, followed by a cornea transplant.
The American Optometric Association has issued a statement confirming that contact lenses are still safe to use despite this incident. Hygiene is extremely important when using contact lenses, particularly the cleanliness of your hands, contact lenses, and contact lens case. Any contaminants on these surfaces may get into the eye upon insertion of the contact lens.
- Sudden blurred or fuzzy vision.
- Red/irritated eyes lasting for an unusually long period of time after removal of the contact lens.
- Pain in and around the eyes.
- Increased sensitivity to light.
- Excessive eye tearing or discharge.
The following six steps are recommended by the American Optometric Association for proper contact lens care:
- Always wash your hands before handling contact lenses.
- Carefully and regularly clean contact lenses.
- Store lenses in clean and proper case. Replace case every three (3) months.
- Use only cleaning products recommended by your optometrist.
- Never re-use old solution
- Replace contact lenses as prescribed by your doctor.
Lenses should be cleaned immediately upon removal using the cleaning solution prescribed by your doctor. Fresh solution should be used each time for cleaning and storage, and the lens case should be replaced every three months. Between disinfection cycles, the lens case should be stored dry. These steps are also effective against Fusarium keratitis infection.
When not properly cared for, contact lenses have been associated with eye infections. Common symptoms of an eye infection include:
If you experience any of these symptoms, it is important to consult your doctor immediately.
If you or a family member have taken Bausch & Lomb ReNu with MoistureLoc and developed a Fusarium keratitis infection, blindness, sudden blurred or fuzzy vision, red irritated eyes, pain in the eyes, excessive sensitivity to light, or excessive tearing or discharge in your eye, then you may have a viable legal claim. We have experience handling mass tort claims and strongly urge you to consult with an experienced ReNu Lawyer as soon as possible.
Have you suffered from the affects from Bausch Lomb Recall Renu with MoistureLoc? Contact us for a free consultation against the Bausch Lomb Recall of Renu with MoistureLoc affecting you today!
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