AMO LENS SOLUTION

by Heidi Turner

The US Food and Drug Administration has announced that it is considering stricter testing standards for contact lens solutions including AMO (Advanced Medical Optics) Complete MoisturePlus. The announcement comes in the wake of a massive recall of the product after it was linked to hundreds of eye infections.

The FDA also convened a panel of ophthalmic researchers, doctors and experts, to discuss the topic of contact lens solutions. At the meeting, the organizations urged the FDA to improve testing of contact lens solutions and adopt universal lens care guidelines.

The organizations advised the FDA to have contact lens solutions tested against a broader range of infectious organisms, to ensure standardized testing for all contact lens products and to ensure contact lens solutions are tested under "real-world" circumstances. Such testing would replicate the conditions under which contact lens solutions and other products are used by consumers rather than the ideal circumstances that are tested for in the lab.

Experts at the FDA hearing noted that so-called improvements to contact lens solutions may have actually increased the risk of infections. Dr. Joseph C. Hutter, chemical engineer reviewer in the Division of Ophthalmic and ENT Devices, told the panel that propylene glycol was added to AMO Complete MoisturePlus to keep the contact lenses wet and increase user comfort. However, the propylene glycol was identified by AMO as a factor that contributed to the Acanthamoeba keratitis outbreak.

AMO Complete MoisturePlus was subject to a massive recall after the product was linked to Acanthamoeba keratitis, a rare parasite that can cause eye infections. The recall was announced following a warning from the US Center for Disease Control and Prevention (CDC) that the risk of developing Acanthamoeba keratitis was seven times greater for people using Complete MoisturePlus than for those using other lens solutions.

Many patients who developed Acanthamoeba keratitis suffered serious eye problems, including difficulty with vision, partial or complete loss of vision and corneal ulcers that required a cornea transplant. Symptoms of the infection include severe eye pain, light sensitivity, redness and discharge.

Complaints against AMO allege that the company knew that Complete MoisturePlus was not as effective at other multipurpose solutions at preventing the growth of some microorganisms but still marketed it as effective. They further allege that the lens solution was responsible for their eye infections and seek compensation for medical costs, some of which include corneal transplants.

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