Why are you initiating a recall?
Advanced Medical Optics (AMO) is immediately and voluntarily recalling its Complete® MoisturePlusTM contact lens solution in response to information provided today by 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. The U.S. Centers for Disease Control and Prevention (CDC) made data available to AMO today showing that it had interviewed 46 patients who had developed Acanthamoeba keratitis (AK) infections reported since January 2005. A total of 39 of these patients were soft contact lens wearers, 21 of whom reported using Complete® MoisturePlusTM products. The CDC estimates a risk of at least seven times greater for those who used Complete® MoisturePlusTM solution versus those who did not. We are acting immediately and decisively out of an abundance of caution in order to protect the eye health of our customers.

Does this recall pertain to all AMO eye care products?
The recall pertains to only AMO Complete® MoisturePlusTM contact lens solution globally. This does not impact any of AMO’s other contact lens products, including our hydrogen peroxide disinfecting solution.

Is this recall due to contamination of your product by Acanthamoeba?
There is no evidence to suggest that today’s voluntary recall is related to a product contamination issue. 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® MoisturePlusTM solution.

What is Acanthamoeba?
Acanthamoeba is commonly found in water, soil, sewage systems, cooling towers, and heating/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/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.

What are the symptoms of Acanthamoeba keratitis (AK)?
Acanthamoeba keratitis (AK) is a rare, but serious, infection of the cornea. 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 Acanthamoeba keratitis 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.

Why does AK occur?
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.

Have you found any correlation between AK and use of COMPLETE® MoisturePLUS™ multipurpose solution in markets outside of the U.S.?
As in the U.S., based on our internal data, we had no reason to believe that our product caused AK. We have not been contacted by any regulatory agencies outside the U.S. regarding AK.

If you haven’t had any AK issues outside the U.S., why did you extend the recall globally?
We conducted the recall on a global basis out of an abundance of caution and in the best interest of our customers.

Is the FDA requiring you to take this action?
AMO is conducting this recall voluntarily and is coordinating our efforts with the FDA.

I have used COMPLETE MoisurePLUS multipurpose solution and I don’t know whether the bottles I used are affected. What shall I do?
We are recalling all lots of COMPLETE MoisurePLUS multipurpose solution. Consumers should discontinue use immediately. If consumers need additional information they should call 0800 376 7950.