FDA Looks to Stricter Rules for AMO Solution

Washington, DCThe US Food and Drug Administration (FDA) is considering stricter testing standards for contact lens solutions such as AMO Complete MoisturePlus. The organization's move is in response to recalls of two lens solutions after they were linked to hundreds of serious eye infections. Meanwhile, people whose eyes were severely affected by the infections are filing lawsuits against AMO.

On June 10, 2008, a coalition of ophthalmic organizations, including the American Academy of Ophthalmology, the Contact Lens Association of Ophthalmologists, the Cornea Society and the American Society of Cataract and refractive Surgery, gave its recommendations about contact lens solutions to the FDA. The organizations urged the FDA to improve product testing and adopt universal lens care guidelines. The coalition noted that the number of cases of microbial keratitis among contact lens wearers has remained relatively stable in spite of voluntary recalls and changes to lens disinfection solutions.

Further recommendations included having contact lens solutions tested against a broader range of infectious organisms, ensuring all contact lens products are subject to standardized testing to ensure they meet the same demands and including testing that involves "real-world" scenarios.

The FDA is also considering updated labeling for contact lens solutions and other lens related items. A possible change to contact lens solution labels would include a warning that consumers should not reuse their lens solution. Updated labeling for other lens products could include a "discard" date and a warning about the risk of eye infection when lenses are worn while swimming or showering.

AMO (Advanced Medical Optics) has already changed its labeling to include a "rinse and rub" instruction. The company reformulated its Complete MoisturePlus contact lens solution after the solution was linked to Acanthamoeba keratitis, a rare waterborne parasite that can cause eye infections.

Although the changes will likely be welcomed by millions of contact lens solution users, they come too late for those who developed serious eye problems last year. Many patients wrote to LawyersandSettlements to report their experiences. They complained of severe eye pain, sensitivity to light, redness, discharge and headaches.

More serious complaints include problems with vision, partial or complete loss of vision and corneal ulcers requiring a cornea transplant. Patients who were affected by AMO's contact lens solution often missed work and incurred costly medical bills while they recovered.

Patients who were affected by AMO Complete MoisturePlus multipurpose contact lens solution are now filing lawsuits against AMO, alleging that the company knew or should have known about the risks to customers. Furthermore, lawsuits also allege that AMO did not adequately notify consumers and retailers that the product was recalled. In fact, some consumers continued using the product well after the recall was announced, unaware that they were putting their eyesight at risk.

If you were injured by the use of AMO Complete MoisturePlus Multipurpose contact lens solution, you may be eligible to join a lawsuit against AMO. Contact a lawyer to discuss your legal options.