AMO COMPLETE® MOISTUREPLUS™ CONTACT LENS SOLUTION

Complete® MoisturePLUS™ is an “all-in-one” multi-purpose contact lens solution that is used to clean soft contact lenses. This product is manufactured by Advanced Medical Optics, Inc.

Advanced Medical Optics Inc. (AMO) engages in the development, manufacture, and marketing of medical devices, including multipurpose lens care products for the eyes. AMO is based in Santa Ana, California. Its product, Complete® MoisturePLUS™, comprised approximately 10% of the contact lens solution marketed in the U.S.

Complete® MoisturePLUS™ has been found to cause acanthamoeba keratitis (AK), a potentially blinding eye infection. Symptoms include pain in one or both eyes, redness, blurry vision and sensitivity to light.

Acanthamoeba is a naturally occurring micro-organism that is found in common substances such as water and soil. It is also found in heating and air conditioning units.

Acanthamoeba keratitis (AK) is a rare, but serious infection of the cornea. It is difficult to treat, and can result in permanent visual impairment or blindness. In the U.S., more than 80% of all cases of this infection involve soft contact lens users who are otherwise in good health. Generally, AK occurs in about one or two out of every one million contact lens wearers, including those who fail to properly clean their lenses after using a swimming pool, hot tub or shower.

On May 26, 2007, Advanced Medical Optics recalled Complete® MoisturePLUS™ from the market. The Centers for Disease Control and Prevention (CDC) has received reports of 138 confirmed cases of acanthamoeba keratitis in people who have used Complete® MoisturePLUS™. Moreover, the CDC estimates that the risk for developing acanthamoeba keratitis is at least seven times greater for persons who have used Complete® MoisturePLUS™, as compared to other solutions.

Estimates show that this represents a 700% increase in risk of severe eye infections (AK) for those who used Complete® MoisturePLUS™ as opposed to those who did not.

If you are a contact lens wearer and have used Complete® MoisturePLUS™ you should consult with your eye doctor if you have any of the following symptoms: eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye, or excessive tearing. The symptoms, which can last several weeks to months, are not the same for everybody. Early in the infection, the symptoms of AK can be very similar to the symptoms of other more common eye infections, but AK eventually may cause severe pain and possible vision loss with some patients requiring a corneal transplant if untreated.

If you have been diagnosed with AK and have used Complete® MoisturePLUS™ you may have a compensable case. Please contact us immediately for a FREE case evaluation. Please complete our short CONFIDENTIAL contact form on the right side of this page or call us immediately at TOLL FREE 1800-467-4000. We will thoroughly examine your case, answer your questions, and inform you of your legal rights and options.

Acanthamoeba Keratitis Facts

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.

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.

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

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.

What can I do to reduce my risk of developing Acanthamoeba keratitis?

These guidelines should be followed by all contact lens users to help reduce the risk of eye infections, including Acanthamoeba keratitis:

Visit your eye care provider for regular eye examinations.
Wear and replace contact lenses according to the schedule prescribed by your eye care provider.
Remove contact lenses before any activity involving contact with water, including showering, using a hot tub, or swimming. Extended-wear contact lens users should discuss concerns with their eye care provider.
Wash hands with soap and water and dry before handling contact lenses.
Clean contact lenses according to the manufacturer's guidelines and instructions from your eye care provider.
1. Use fresh cleaning or disinfecting solution each time lenses are cleaned and stored. Never reuse or top off old solution.
2. Never use saline solution and rewetting drops to disinfect lenses. Neither solution is an effective or approved disinfectant.
Store reusable lenses in the proper storage case.
1. Storage cases should be rinsed with sterile contact lens solution (never use tap water) and left open to dry after each use.
2. Replace storage cases at least once every three months.

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.

FDA Issues Safety Alert to all doctors on Complete® MoisturePLUS™ Contact Lens Solution

FDA Preliminary Public Health Notification*: Acanthamoeba Keratitis Infections Potentially Related to Complete MoisturePlus Multipurpose Contact Lens Solution Manufactured by Advanced Medical Optics (AMO)

Issued : May 31, 2007

Dear Healthcare Practitioner:

This is to inform you of a recent increase in reported cases of Acanthamoeba keratitis in soft contact lens wearers. A Centers for Disease Control and Prevention (CDC) investigation of cases since January 2005 indicates a potential association with the use of Complete MoisturePlus Multipurpose Contact Lens Solution, manufactured by Advanced Medical Optics (AMO). Acanthamoeba keratitis, caused by a free-living amoeba that is relatively common in the environment, is a rare but serious eye infection that may cause vision loss requiring corneal transplants. AMO has announced a voluntary recall of this product as a precaution.

Both the Food and Drug Administration (FDA) and the CDC are investigating this situation.
Recommendations

If a patient presents with an infectious keratitis, consider that an Acanthamoeba infection may be involved,
When appropriate, refer the patient to an eye care professional to obtain a specimen (e.g., corneal scrapings) for laboratory analysis and for initiation of immediate treatment.
Report cases of Acanthamoeba keratitis in contact lens wearers to FDA as noted below.
Instruct contact lens wearers using AMO Complete® MoisturePlus solution to:
o Stop using this product immediately and contact the company at 1-888-899-9183 for instructions on what to do with unused solution.
o Replace their lenses and storage container.
Consult their doctor about choosing another cleaning/disinfecting product.
Consult an eye care professional if they have symptoms of eye infection such as redness, pain, excessive tearing, increased light sensitivity, blurry vision, and/or sensation of something in the eye. This is important because early diagnosis of Acanthamoeba keratitis is important for successful treatment.

Investigation of the Acanthameoba Cases

In an MMWR Dispatch dated May 26, 2007, CDC stated that it has identified 138 cases of culture-confirmed Acanthamoeba keratitis in 35 states and Puerto Rico. Although the majority of case-patients have yet to be interviewed, complete patient data are available for 46 of them. Thirty-nine of the 46 wore soft contact lenses. Information obtained by CDC from patient interviews indicates that of 36 patients who used any contact lens solution, 21 (58%) used AMO Complete MoisturePlus brand contact lens solution in the month prior to the onset of symptoms. CDC determined that patients with Acanthamoeba keratitis were at least 7 times more likely to have used the AMO Complete MoisturePlus solution compared with a group of healthy adult soft contact lens users. Of 37 case-patients for whom clinical information is available, nine patients (24%) have either required or are expected to undergo corneal transplantation.

CDC and FDA are investigating these case reports. Also, investigations by CDC, state and local health departments, FDA, and AMO are underway to further define specific behaviors or products that place contact lens wearers at increased risk for Acanthamoeba keratitis.
Background on Acanthamoeba Keratitis

Acanthamoeba keratitis, a rare but potentially blinding infection of the cornea, is caused by a ubiquitous, free-living amoeba (Acanthamoeba) that is found commonly in the environment, including water (e.g., tap and recreational water), soil, sewage systems, cooling towers, and heating/ventilation/air conditioning (HVAC) systems. The infection primarily affects otherwise healthy persons who wear contact lenses; an estimated 85% of U.S. cases occur in contact lens wearers (including wearers who follow recommended contact lens-care practices). Certain contact lens users are at increased risk for infection, including those who improperly store, handle, or disinfect their lenses (e.g., by using tap water or homemade solutions for cleaning); swim, use hot tubs, or shower while wearing lenses; come in contact with contaminated water; have minor damage to their corneas; or have previous corneal trauma. Based on an analysis of cases reported to CDC during 1985 - 1987, the incidence of Acanthamoeba keratitis in the United States has been estimated at one to two cases per million contact lens users. An estimated 30 million persons in the United States wear soft contact lenses.
Reporting Adverse Events

In order to more clearly establish the etiology of these infections and their possible relationship to contact lens products, FDA and CDC are gathering information on Acanthamoeba keratitis in contact lens users. We encourage you to report these infections to FDA, and we will share the reported information with CDC.


Sincerely yours,
Daniel G. Schultz, MD

Director
Center for Devices and Radiological Health
Food and Drug Administration

If you have been diagnosed with AK and have used Complete® MoisturePLUS™ you may have a compensable case. Please contact us immediately for a FREE case evaluation. Please complete our short CONFIDENTIAL contact form on the right side of this page or call us immediately at TOLL FREE 1800-467-4000. We will thoroughly examine your case, answer your questions, and inform you of your legal rights and options.