SANTA ANA, Calif. In an Advanced Medical Optics presentation before the Food and Drug Administration’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee on Tuesday, the company addressed several general issues regarding the safety and effectiveness of contact lens solutions and demonstrated that infection control is a complex issue that involves more than the formulation of the solution itself.
“Rub and rinse has been proven to improve effectiveness against Acanthamoeba and other microorganisms,” stated David Hansen, director of professional services, AMO. “We firmly believe that it should be an integral part of an effective contact lens hygiene regimen.”
The company, which manufactures the Complete brand of eye care products, also shared information on ways to minimize the risk of infections such as Acanthamoeba keratitis among people who wear contact lenses and underscored the importance of proper handling, disinfection and hygiene when using contact lenses and contact lens products.
The company also addressed the FDA’s interest in evaluating preclinical microbiology test methods to better serve as predictors of real world product performance. AMO supports establishing standards for testing the effectiveness of contact lens solutions in effectively disinfecting against a broad range of organisms in the best interest of the patients who use its products. “We look forward to collaborating with the FDA on the most effective and appropriate path forward because we share their interest in controlling infections,” said Trenary. “Per our routine policy, we will comply with new FDA standards and/or labeling decisions and take any requested actions within the allotted timeframe.”