The Centers for Disease Control and Prevention (CDC), in concert with the Food and Drug Administration, state and other partners, has identified the outbreak called Acanthamoeba keratitis (AK). This infection is caused by a free-living ameba (Acanthamoeba) which is 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.  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.

People who wear soft contact lenses and who use Advanced Medical Optics (AMO) CompleteR MoisturePlusTM Multi-Purpose Solution are advised to:

• Stop using the product immediately and discard all remaining solution including partially used or unopened bottles.  Choose an alternative contact lens solution.
• Discard current lens storage container.
• Discard current pair of soft lenses
• See a health care provider if experiencing any signs of eye infection: Eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye, or excessive tearing.

Acanthamoeba keratitis is caused by a parasite, can be difficult to detect and is hard to treat. This outbreak has involved at least 138 patients.

The outbreak last year was linked to a different manufacturer’s lens solution and a different microbe. In both instances, the cornea, the eye’s transparent outer covering, is at risk. But why two different microbes caused the outbreaks is not known at this time.

Last year, the outbreak of fusarium keratitis was caused by a fungus; there were 164 confirmed cases. It was linked to ReNu With MoistureLoc made by Bausch & Lomb, but how the product caused the problem is unknown.

AMO said they are pulling their product and that there was no evidence to suggest that its product was contaminated with acanthamoeba. 

• The outbreak of Fusarium keratitis was associated with the use of ReNu with MoistureLoc
• The unique properties of ReNu with MoistureLoc formula may have contributed to the outbreak of fungal infections
• The Fusarium keratitis was likely caused as a result of extrinsic contamination of the contact lens solution bottle or contact lens cases outside the manufacturing or storage process
• Suboptimal hygiene practice appeared unlikely to contribute to the outbreak
• Biofilm on the contact lenses or contact lens cases may have played a role in the outbreak
• Some hygiene practices may have facilitated the growth of biofilms
• Fusarium may have specific qualities promoting adherence and penetration into the contact lenses that allow survival within contact lens cases when used with ReNu with MoistureLoc

• Stop using Bausch & Lomb ReNu with MoistureLoc products and discard all remaining MoistureLoc solution, including partially used or opened bottles.
• Consult your eye care professional for a recommendation for an appropriate alternative cleaning/disinfecting product.
• Consider performing a "rub and rinse" lens cleaning method, rather than a no-rub method, regardless of which cleaning/disinfecting solution is used. That will minimize the number of germs and reduce the chances of infection.

Continue to follow proper lens care practices:

• Wear and replace lenses according to the schedule prescribed by the doctor.
• Wash hands with soap and water, and dry (lint-free method) before handling lenses
• Follow the specific lens cleaning and storage guidelines from your doctor and the solution manufacturer.
• Keep the contact lens case clean and replace every 3 to 6 months.
• Remove the lenses and consult your doctor immediately if you experence symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge, or swelling.

The FDA has posted these updated recommendations for health care providers:

• Advise patients to stop using Bausch & Lomb ReNu with MoistureLoc products immediately, discard all remaining MoistureLoc solution, and use an alternative cleaning/disinfecting product.
• If a patient has microbial keratitis, consider that a fungal infection may be involved. Prior to initiating immediate treatment, an eye care professional should obtain a specimen for laboratory analysis.
• Report cases of fungal keratitis in contact lens wearers to the FDA.

• Of the 14 cases in Tennessee, 10 involved the use of Renu with Moisture-Loc.
• 6 cases of the infection in Tennessee resulted in serious injury requiring corneal transplants.
• Across the country, the CDC reports 122 confirmed cases.

• 56 wear contact lenses;
• 32 reported using any B&L ReNu with MoistureLoc;
• 15 reported using any B&L ReNu MultiPlus;
• 7 reported using any unspecified B&L ReNu;
• 3 reported using any AMO product;
• 3 reported using any Alcon product

• Use of tap water during lens care (to rinse lenses or the storage case)
• Wearing lenses while swimming (without goggles), showering or in hot tubs
• Use of ineffective lens care solutions
• Failure to follow lens care instructions