Advanced Medical Optics (AMO) in association with the U.S. Centers for Disease Control and the U.S. Food & Drug Administration (FDA) is voluntarily recalling a contact cleansing solution called Complete® MoisturePlus™ Multi-Purpose Solution. The solution contains two-tear like moisturizers, electrolytes and taurine which relieves eye dryness associated with contact lenses.
Complete® MoisturePlus™ Multi-Purpose Solution can be purchased over-the-counter at local drug stores. It is used by contact lenses wearers for the disinfection, cleaning, protein removal and conditioning of contact lenses.
Based on reports from the Center for Disease Control, in May of 2007, the FDA reported a voluntary recall of Complete® MoisturePlus™ Multi-Purpose Solution manufactured by Advanced Medical Optics.
The recall was in response to eye infections from Acanthamoeba, a naturally occurring water-borne organism known to cause serious corneal infections. The CDC released information from 46 patients who had developed Acanthamoeba keratitis (AK) since January 2005. A total of 39 of these patients were soft contact lens wearers, 21 of whom reported using Complete® MoisturePlusTM products.
Patients who wear contact lenses are urged to contact 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, vary from person to person. 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 blindness or require corneal transplants in worse case scenarios.
Consumers who believe they are in possession of Complete® MoisturePlus™ Multi-Purpose Solution should discontinue use immediately and call 1-888-899-9183. Advanced Medical Optics is currently contacting retailers, customers and distributors regarding return and replacement instructions. Reply cards and mailing slips are being provided for return of product. Retailers may also call 1-888-899-9183 for more information.
Anyone allergic to the product’s ingredients should refrain from using Complete Moisture Plus Multi-Purpose Solution. The COMPLETE® brand Multi-Purpose Solution is a sterile, isotonic, buffered, solution with ingredients including hydroxypropyl methylcellulose and propylene glycol as lubricants, preserved with polyhexamethylene biguanide 0.0001%, phosphate and taurine as buffers, Poloxamer 237 as a surfactant, edetate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water.
How is Acanthamoeba keratitis spread?
Acanthamoeba is a microorganism discovered 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 most commonly suffered by 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.
I wear contacts, am I at risk for Acanthamoeba?
The incidence of AK in the United States has been estimated by CDC at approximately one to two cases per million contact lens users. If you have used Complete® MoisturePlus™ Multi-Purpose Solution and suffer eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye or excessive tearing, immediately contact your eye doctor to seek treatment for Acanthamoeba as you may be at risk. Although the illness is relatively rare, poor contact lens hygiene will increase your risk of contracting Acanthamoeba.
Can I file a lawsuit if I have suffered damages from taking Complete Moisture Plus?
Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has experienced any health problems while taking Complete Moisture Plus, you should contact your doctor immediately. You may also wish to contact an experienced Complete Moisture Plus lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.