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U.S. Department of Health and Human Services

Medical Devices

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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 ameba 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:
    • Stop using this product immediately and contact the company at 1-888-899-9183 for instructions on what to do with unused solution.
    • 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.

Information for consumers about this topic, as well as general recommendations for contact lens wearers, can be found in “FDA Advice to Patients”.

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. The MMWR Dispatch can be found online.  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.

You can report directly to the FDA's MedWatch Adverse Event Reporting program online. by phone 1-800-FDA-1088, by fax 1-800-FDA-0178 or by returning the postage-paid FDA form 3500 which may be downloaded by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

Please include the following information (if available) on the MedWatch reporting form:

  • The trade names and lot numbers of the contact lens solutions
  • The contact lens type, trade name and mode of wear (extended or daily wear)
  • Patient non-compliance with contact lens regimen (e.g., overnight wear in daily wear lenses, not cleaning lenses)
  • Results of all cultures taken (e.g., corneal, conjunctival, contact lens, care solutions, lens case)
  • Diagnostic methodology used in addition to or in lieu of cultures, and its findings
  • Special patient characteristics, including whether the patient was immunocompromised (e.g., used topical or systemic corticosteroids or had diabetes), or had any ocular trauma, surgery, or chronic eye problem
  • Treatment regimen utilized
  • Whether a corneal transplant was required or is planned

Getting More Information

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.

 

 

FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.

Sincerely yours,

Daniel G. Schultz, MD

Director
Center for Devices and Radiological Health
Food and Drug Administration

*CDRH Preliminary Public Health Notifications are intended to quickly share device-related safety information with healthcare providers when the available information and our understanding of an issue are still evolving. We will revise them as new information merits and so encourage you to check this site for updates.

 

If you have questions about this Notification, please contact FDA's  Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at dsmica@fda.hhs.gov or by phone at 1-800-638-2041 or 301-796-7100