Fungal Infection

FOR IMMEDIATE RELEASE

In response to information received today from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections, Advanced Medical Optics (AMO) (NYSE:EYE - News) is immediately and voluntarily recalling its Complete® MoisturePlus(TM) contact lens solutions. CDC data was made available to AMO today showing that it had completed interviews with 46 patients who had developed Acanthamoeba keratitis (AK) since January 2005. A total of 39 of these patients were soft contact lens wearers, 21 of whom reported using Complete® MoisturePlus(TM) products. The CDC estimates a risk of at least seven times greater for those who used Complete® MoisturePLUS(TM) solution versus those who did not.


While AMO continues to work with the CDC and the U.S. Food and Drug Administration (FDA) to further assess the data, it is acting with an  abundance of caution to voluntarily recall Complete® MoisturePlus(TM) from the market. There is no evidence to suggest that today's voluntary recall is related to a product contamination issue and this does not impact any of AMO's other contact lens care products, including our family of hydrogen peroxide disinfecting solutions. As patient safety is paramount to AMO, the company is taking decisive action to stop shipments, recall product from the marketplace, and encourage consumers to discontinue the use of AMO Complete® MoisturePlus(TM) until further information is available. Given the potential seriousness of the reported Acanthamoeba infections, AMO is working in close partnership with the CDC, the FDA and others to make sure consumers are aware of the need for proper contact lens disinfection and proper lens handling.

Acanthamoeba is a microorganism commonly found in water, soil, sewage systems, cooling towers, and heating/ventilation/air conditioning (HVAC) systems. Acanthamoeba keratitis (AK) is a rare, but serious, infection of the cornea. AK is usually found among individuals who improperly store/handle/disinfect their lenses (e.g., use tap water or homemade solutions for cleaning), swim/use hot tubs/shower while wearing lenses, come in contact with contaminated water, have minor damage to their corneas, or have previous corneal trauma. The incidence of AK in the United States has been estimated by CDC at approximately one to two cases per million contact lens users.

Contact lens wearers should consult with their eye doctor if they have any of the following symptoms: eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye, and 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 may eventually cause severe pain and possible vision loss with some patients requiring a corneal transplant if untreated.

Consumers who believe they are in possession of the recalled product should discontinue use immediately and call 1-888-899-9183. The company is currently contacting retailers, customers and distributors regarding return and replacement instructions. Reply cards and mailing slips are being provided for return of product. Retailers may also call 1-888-899-9183 for more information.

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The American Optometric Association’s (AOA) Contact Lens and Cornea Section (April 1, 2006) urges contact lens wearers to take proper precautions amid reports of a potentially sight-threatening eye fungus appearing in the United States.  The New York State and the New Jersey Department of Health have issued an alert, that they are investigating three (3) cases of Fusarium keratitis.  This is a a severe corneal fungal infection that has recently been linked to soft contact lens use. Optometrists in Florida and Iowa also have reported seeing similar cases in patients.  In Asia the fusarium keratitis has been associated with Renu disinfecting solution, which has been voluntarily removed from distribution.

Health officials have not yet determined whether the cases in the United States are directly related to outbreaks in Asia. Treatment for Fusarium keratitis includes anti-fungal medication. However, some patients have reportedly experienced a significant loss of  vision, resulting in the need for a corneal transplant.  It is imperative that contact lens wearers use proper hygiene in handling of their contact lenses, are aware of any potential vision problems and alert their eye doctors if any unusual symptoms occur.

Anyone who experiences the following symptoms should contact this office immediately 

• 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

• Excessive eye tearing 

More than 30 million Americans wear contact lenses, according to the Contact Lens Institute. There have been only 3 reported cases (1 in a million)

 Top 5 Recommendations for Clean and Safe Contact Lenses

1. Carefully and regularly clean contact lenses

2. Rub the contact lenses with fingers and rinse thoroughly before soaking the lenses overnight in enough multi-purpose solution to completely cover the lens.

3. Store lenses in the proper case and replace the lens storage case every three months. Clean the contact lens case after each use and keep the case open and dry between cleanings.

4. Use the proper products to clean and disinfect contact lenses. Remember that saline solutions and rewetting drops are not designed to disinfect lenses.

5. Only fresh solution (either Opti-free or Clear Care) should be used to clean and disinfect contact lenses. Never re-use old solution. Contact lens solution must be changed everyday, even if the lenses are not used daily. 

When wearing or cleaning contacts:

• Do not use cream soaps to wash hands before cleaning contact lenses. Cream soaps can leave a film on the hands that can be transferred to the lenses.

• Never put contact lenses in the mouth or moisten them with saliva, which is full of bacteria and a potential source of infection.

• Don’t use tap water or homemade saline solutions. Improper use of solutions has been linked to a potentially blinding condition among soft lens wearers.

• Never use contacts that have not been prescribed by an eye doctor. Contact lens wearing is not an option for everyone.