CDC Warns About Contact Lens Solution

ATLANTA - Government officials are warning people to throw away a contact lens solution after an investigation linked it to a rare eye infection.

The warning concerns AMO Complete Moisture Plus Multi-Purpose Solution, used for cleaning and storing soft contact lenses, said a spokeswoman for the U.S. Centers for Disease Control and Prevention.

The solution seems to be a factor cases of Acanthamoeba keratitis, a painful eye infection that can lead to permanent vision loss or blindness.

The CDC and the U.S. Food and Drug Administration are investigating 138 confirmed cases.

The solution is made by Advanced Medical Optics Inc., a publicly traded company based in Santa Ana, Calif. A message left with a company spokesman was not immediately returned.

CDC officials said people should discard the solution, throw out their current contact lenses and toss the lens storage case. All of them may harbor the infecting amoeba, said Michael Beach, team leader in the CDC's division of parasitic diseases.

An estimated 85 percent of U.S. cases of Acanthamoeba keratitis occur in contact lens users, but it's extremely unusual _ the estimated prevalence is one to two cases per 1 million contact lens wearers. Contact lens wearers who practice proper lens care and people who don't wear contact lenses can still develop the infection.

It's hard to diagnose and treat _ and some of the drugs used to fight the infection are available only overseas or from compounding pharmacies.

The government's investigation began in 2004, when a University of Illinois-Chicago ophthalmologist _ Dr. Elmer Tu _ noticed more than a dozen cases of the infection. Normally, he might see only one or two in a year, Tu said.

UIC doctors saw 35 patients with the condition from May 2003 through September 2006. About 55 percent used the Advanced Medical Optics product exclusively, Tu said.

UIC investigators think the infection is not originating in the manufacturing process, but that the cleaning solution is not protecting people from the infection, which they get in their eyes through showering or swimming, Tu said.

The amoeba that causes the infection is naturally present in soil and water. Wearing contact lenses while swimming or in the hot tub appears to increase the risk of infection.

The cases were reported to the Illinois state health department, which notified the CDC. A CDC investigation in about 35 states led to Friday's announcement.

The solution is not marketed to protect against the amoeba. But "it's supposed to be free of any type of microorganisms. It's not supposed to result in anyone getting an infection," said Julie Zawisza, an FDA spokeswoman.

The FDA will take information from the CDC investigation and try to discern what about the solution _ or how people were using it _ could be responsible for the infection cases, she added.

Health officials have interviewed 46 of the patients so far. Of those 36 wear soft contact lenses, and 21 use the Advanced Medical Optics solution, Beach said. It was a strong enough association to cause health officials to issue Friday's warning, Beach said.

Dozens of cases of this rare condition can be significant, eye experts said.

"It's a large number if it's happening to you. It's a large number if there is a little pocket of it. It's not a large number if you consider there are 35 million contact lens wearers in the United States," said Dr. William Ehlers, a University of Connecticut Health Center ophthalmologist.

The investigation is the second into eye infections associated with contact lens solution undertaken by the CDC and FDA in the past year. In 2006, a Bausch & Lomb multipurpose contact lens solution was linked to a fungal eye infection called Fusarium.

This week, Advanced Medical Optics disclosed it was considering making a bid to buy Bausch & Lomb, its eye-care products rival.

Associated Press writer Andrew Bridges contributed to this report from Washington.

On the Net:

CDC information on Acanthamoeba:

http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm

A service of the Associated Press(AP)

Recall is on per FDA:

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, discard all partially-used or unopened bottles and replace their lenses and storage container.

"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 http://www.cdc.gov/mmwr.

"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."

All contact lens users should closely adhere to the following measures to help prevent eye infections:

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

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.

Additional information about Acanthamoeba infection is available from the CDC website at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm

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