Advanced Medical Optics (AMO) has announced an immediate recall of its COMPLETE® MoisturePLUS™ contact lens solution. The recall is being initiated because of concerns over eye infections from Acanthamoeba, a naturally occurring water-bourne organism which can contribute to serious corneal infections.
There is no evidence to suggest that today’s recall is related to a product contamination issue and this does not impact any of AMO’s other contact lens care products, including hydrogen peroxide disinfecting solutions.
The U.S. Centre for Disease Control and Prevention (CDC) made data available to AMO 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.
The incidence of AK infections has been estimated by the CDC at approximately one to two cases per million contact lens wearers. Acanthamoeba is an organism commonly founding water, soil, sewage systems, cooling towers, and heating/air-conditioning systems. AK infections are usually found among individuals who improperly store/handle/disinfect their lenses (e.g. use tap water to clean lenses, swim or shower while wearing lenses or come in contact with contaminated water, especially is the corneal has been damaged)
If you are a contact lens wearer and have any of these symptoms, you should consult your optometrist: eye pain, eye redness, blurred vision, sensitivity to light, sensation of some thing in the eye, and excessive tearing. The symptoms, which can last several months, 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 people requiring a corneal transplant, if untreated.
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
If you use COMPLETE® MoisturePLUS™ contact lens solution products, please follow these steps
1. Check to ensure that the COMPLETE® product you have is a COMPLETE® MoisturePLUS™ contact lens solution product. This recall only pertains to COMPLETE® MoisturePLUS™ contact lens solution; all other COMPLETE® product is unaffected.
2. If you are using a COMPLETE® MoisturePLUS™ contact lens solution product please discontinue use immediately
3. If you require further information call and to arrange for a refund call 0800 376 7950
4. If you have used a COMPLETE® MoisturePLUS™ contacts lens solution product and are experiencing any problems with your eyes, consult your eye care professional immediately.
5. Please report any adverse reactions experienced with the use of this product by calling 01628551621