MEDIA

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 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 Oxysept 1step.

Is this recall due to contamination of your product by Acanthamoeba?
There is no evidence to suggest that the 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/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.

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.

How long ago did you learn about this problem?
We were notified of the CDC’s data on Friday morning, May 25th and issued a voluntary recall a few hours later.

Did the study conducted by Dr. Joslin and Elmer Tu at the University of Illinois at Chicago show a connection between Complete and AK?
We are not aware of any correlation uncovered in the University of Illinois at Chicago study. The published study did not include any reference to contact lens solutions or AMO products.

Has this issue been reported to the U.S. Food and Drug Administration (FDA)?
Yes. We have been working closely with both the FDA and the CDC on this issue.

What’s wrong with the recalled contact lens solution?
There is no evidence to suggest product contamination. The recall is based on the data provided by the CDC. AMO will continue to work with the CDC and FDA to assess the situation.

Has AMO received any consumer complaints of AK?
Looking back over the past few years, we’ve had a limited number of AK reports. However, we had no reason to believe that our product caused AK, based on the customer complaints we received.

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 this recall related to the problems you had last year in China with product quality?
No. Our recall last year was due to an isolated production line issue at our China facility and has been resolved.

What should someone do if they used CompleteMoisurePlus?
We recommend they immediately stop using the recalled product. If they feel there is anything wrong with their eyes, they should consult their eye care practitioner immediately.

Where were the products manufactured and have those facilities been inspected by the FDA?
Products were manufactured at our plants in Spain and China. We successfully concluded an inspection of the China plant earlier this week, with no deficiencies noted at the conclusion of the inspection.

How will this impact your dry eye product launch?
At the current time, we are fully focused on implementing the recall and serving the needs of customers. We cannot determine whether and how this might affect launch dates of new products.

RETAILERS / OPTICAL CHAINS

How are you planning to announce this recall to the general public?
We are disseminating a press release with the recall information, as well as sending letters to our retailer customers and eye care practitioners.

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

What do I do if I have stock of the affected product?
You will soon be receiving instructions from us about how to record the stock you have in your store and how to return this to us.

What shall we tell our consumers who want to return COMPLETE®MoisturePLUS™ solution?
We are asking all of our customers to immediately discontinue use of the product and recommend that they return it their Optician who will give advice on an alternative solution.

CONSUMERS

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 and return product to their Optician.

What could happen to my eyes if I used the affected product?
AK is a rare, but serious infection. Symptoms include eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye, and excessive tearing. Symptoms can last for several weeks to months and 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.