AMO MoisturePlus Recall

Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens Solution
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The U.S. Food and Drug Administration is alerting health care professionals and their patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution manufactured by Advanced Medical Optics of Santa Ana, Ca.

The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC).

Consumers who wear soft contact lenses should stop using the solution, but preserve it, along with the lenses & cases in seperate, sealed plastic bags in a manner consistent with the manufacturer's storage instructions for the production until the products can be provided to an attorney or a lab to be tested for bacteria or fungus. DO NOT discard these items, as doing so may impair your ability to present evidence in support of your claims.

"We believe the company acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA and CDC are working closely with the company to collect additional information and we will continue to alert consumers and advise them as more information becomes available."

Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses.

Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment. The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing but Acanthamoeba is more difficult to treat.

It is estimated that Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. However, in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, CDC determined that the risk of developing AK was at least seven times greater for those consumers who used Complete MoisturePlus solution versus those who did not. Additional information regarding the CDC results is available at the CDC website.

"The ongoing CDC investigation is a collaborative effort," said Michael Beach, M.D., a Division of Parasitic Diseases team leader with CDC. "We are working with FDA, state, territory, university, and clinical partners in an effort to further understand whether usage or contamination of this solution led to these Acanthamoeba infections."

FDA and CDC want to gather information related to Acanthamoeba keratitis in contact lens users. Report adverse events related to these products to MedWatch, the FDA's voluntary reporting program: www.fda.gov/medwatch/report.htm; Phone: (800) 332-1088; Fax: (800) 332-0178; Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

Consumers who believe they are in possession of the recalled product may call the company at 1-888-899-9183.

If you or a loved one have used Advanced Medical Optics (AMO) Complete MoisturePlus Multi-Purpose Solution and suffered an eye infection, contact the Contact Lens Solution Recall attorneys at TKO today . You may be entitled to compensation.

Distributed via Health Alert Network
Friday, May 25, 2007, 21:39 EDT (09:39 PM EDT)
CDCHAN-00260-2007-05-25-ADV-N

Early Report of Serious Eye Infections Associated with Soft Contact Lens Solution

The Centers for Disease Control and Prevention (CDC), collaborating with the Food and Drug Administration, state and other partners, has identified an outbreak of a serious but rare eye infection called Acanthamoeba keratitis (AK). This infection is caused by a free-living ameba (Acanthamoeba) a microscopic organism found everywhere in nature. Infections can result in permanent visual impairment or blindness. AK primarily affects otherwise healthy people, most of whom wear contact lenses. In the United States, an estimated 85% of cases of this infection occur in contact lens users. The incidence of the disease in the U.S. is approximately one to two cases per million contact lens users.

CDC has received reports of 138 cases of culture-confirmed AK in 35 states and Puerto Rico, with complete patient data available for 46 case-patients.  Thirty-nine of the 46 case-patients wore soft contact lenses. Preliminary information obtained by CDC from patient interviews indicates that, among soft contact lens users who reported the use of any type of solution, 21 (58%) reported having used Advanced Medical Optics (AMO) CompleteR MoisturePlusTM Multi-Purpose Solution in the month prior to symptom onset.  Out of the 37 case-patients for whom clinical data was available, 9 (24%) failed medical therapy and required or are expected to undergo corneal transplantation.

Based on these findings people who wear soft contact lenses who use Advanced Medical Optics (AMO) CompleteR MoisturePlusTM Multi-Purpose Solution should stop using the solution, but preserve it, along with the lenses & cases in seperate, sealed plastic bags in a manner consistent with the manufacturer's storage instructions for the production until the products can be provided to an attorney or a lab to be tested for bacteria or fungus. DO NOT discard these items, as doing so may impair your ability to present evidence in support of your claims.

Clinicians evaluating contact lens users with symptoms of eye pain or redness, tearing, decreased visual acuity, discharge, sensitivity to light, or foreign body sensation should consider AK and refer the patient to an ophthalmologist, if appropriate. Diagnosis requires a high degree of suspicion, especially in a contact lens wearer with a recent diagnosis of another form of keratitis, such as herpes simplex virus keratitis, who is not responding to therapy.  Diagnosis is made on the basis of clinical picture and isolation of organisms from corneal culture or detection of trophozoites and/or cysts on histopathology.  However, a negative culture does not necessarily rule out Acanthamoeba infection. Confocal microscopy and polymerase chain reaction assays to detect Acanthamoeba may also assist with diagnosis. Early diagnosis can greatly improve treatment efficacy.

Clinicians should consider obtaining clinical specimens (e.g., corneal scrapings) for culture before initiating treatment. Clinicians or microbiology laboratories should report cases of AK to state and local health departments or directly to CDC at telephone, 770-488-7775. Acanthamoeba isolates should be submitted to state laboratories according to instructions provided by local and state public health laboratories.

Additional information about Acanthamoeba infection is available from the CDC website.

Infection of the Eye with Acanthamoeba (A-kanth-a-ME-buh)

• What is Acanthamoeba keratitis?
• What are the symptoms of infection?
• Who is at risk for infection?
• How is Acanthamoeba diagnosed and treated?

What is Acanthamoeba keratitis?

Acanthamoeba keratitis is a rare but serious infection of the eye that can result in permanent visual impairment or blindness. The infection is caused when a microscopic, free-living ameba called Acanthamoeba invades the transparent outer covering of the eye called the cornea. These amebas are very common in nature and can be found in all areas of the environment, including water, soil, and air.

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What are the symptoms of infection?

Early in the infection, the symptoms of Acanthamoeba keratitis can be very similar to the symptoms of other more common eye infections. The symptoms, which can last several weeks to months, are not the same for everybody and might include:

• Eye pain
• Eye redness
• Blurred vision
• Sensitivity to light
• Sensation of something in the eye
• Excessive tearing

Patients should consult with their eye doctor if they have any of the above symptoms. Acanthamoeba keratitis will eventually cause severe pain and possible vision loss or blindness if untreated.

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Who is at risk for infection?

Acanthamoeba keratitis primarily occurs in people who wear contact lenses, but anyone can develop the infection. Individuals with safe contact lens-care practices can develop infection. However, there are several practices among contact lens users that increase the risk of getting Acanthamoeba keratitis including:

• Improper storage and handling of lenses
• Improper disinfection of lenses (such as using tap water or homemade solutions to clean the lenses)
• Swimming, using a hot tub, or showering while wearing lenses
• Coming into contact with contaminated water
• Having a history of trauma to the cornea

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How is Acanthamoeba keratitis diagnosed and treated?

Early diagnosis is essential for effective treatment of Acanthamoeba keratitis. The infection is usually diagnosed by an eye specialist based on symptoms, growth of the ameba from a scraping of the eye, and/or seeing the ameba by a process called confocal microscopy. The infection is treated with one or more prescription eye medications. The infection can sometimes be difficult to treat and the best treatment regimen for each patient should be determined by an eye specialist.

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This fact sheet is for information only and is not meant to be used for self-diagnosis or as a substitute for consultation with a health care provider. If you have any questions about the disease described above or think that you may have a parasitic infection, consult a health care provider.

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