Dear customer,

We want to inform you that Advanced Medical Optics (AMO) is initiating a voluntary and immediate recall of its COMPLETE® MoisturePLUS™ contact lens solution. The recall results from an information received end of last week from the U.S. Centers of Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections.

The CDC made data available to AMO on May 25 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. This recall is being conducted on a voluntary basis, in cooperation with the respective regulators.

While AMO continues to work with the CDC and the U.S. Food and Drug Administration (FDA) to further assess the data, it is acting with an abundance of caution and has decided to remove AMO Complete® MoisturePlusTM from the market. There is no evidence to suggest that today’s voluntary recall is related to a product contamination issue and this does not impact any of AMO’s other contact lens products, including our family of hydrogen peroxide disinfecting solutions. As user 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.

Please examine your inventory immediately for recall product.

1. With immediate effect please stop the sale of all AMO Complete® MoisturePlusTM products and remove all unsold goods from your shelves ready to be collected.
2. Please use the attached form to immediately audit your Complete® MoisturePlusTM stock.
3. This form needs to be faxed back to us +46-8-59072693 within 48hrs
4. Please keep a copy of the completed fax back form and place it with the returning stock. We will arrange collection.

If you have distributed the Complete® MoisturePlusTM to other retailers you should immediately notify them of this recall. Upon request, AMO will provide a template letter for you to provide to these retailers.

While AMO believes the likelihood of users experiencing an adverse reaction is low, we have taken a conservative approach and are conducting the recall in the best interests of our customers.

We apologize for the inconvenience this has caused. AMO has built its reputation on consumer trust and the assurance that we provide products that meet the highest standards. Our first priority is protecting the ocular health of those who use our products and as such, we appreciate your assistance with this matter.

Please do not hesitate to contact us through your normal customer service number.

Regards,

Clive Sutton
Regional Sector Manager Eyecare (UK Nordics)