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Breaking News aboutMoisturePLUS by AMO According to a press release posted (5/25/07) by the FDA regarding the recall and market withdrawal by AMO, the company has announced the recall of "Complete Moistureplus Multipurpose Solution." Based on information from the CDC, (U.S. Centers for Disease Control and Prevention), severe eye infections have been caused by this product. The parasite, Acanthamoeba, can be a key factor in causing serious corneal infection in users of Advanced Medical Optics MoisturePLUS product. AMO has thus decided that it must recall Complete MoisturePlus contact lens solution. The CDC data shows that 46 patients developed Acanthamoeba keratitis (AK) since January 2005, many after using Moistureplus. 39 of these patients were soft contact lens wearers. 21 of the people with these eye infections had used Complete MoisturePlus products. Estimates show that this represents a 700% increase in risk of severe eye infections (Acanthamoeba keratitis) from for those who used Complete® MoisturePLUSTM solution comapred to those who did not. AMO will certainly be faced with losses in business and it is likely that many lawsuits will be filed for people who were injured by this product. The CDC and the FDA are taking cautious steps and AMO had to remove Complete MoisturePlus from the market. While it does note appear that this problem is from contamination, it is clear that there is a real problem with this product made by AMO. Since patient safety is claimed to be paramount to AMO in their press release, we can only assume that the company will stop shipments, recall product, and encourage consumers to discontinue the use. Is the above information enough? From our experience with ReNu, issuing a press release and taking the above steps alone will not be sufficent to stop people from unknowingly continuing to use the product. We believe that AMO should also take out ads in major newpapers and on television to aggressively warn consumers of this problem. Acanthamoeba is a microorganism 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. 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 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. |
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