The U.S. Food and Drug Administration (FDA) are warning patients and health care professionals that wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution that is manufactured by Advanced Medical Optics.
The company is recalling the product as a precautionaru measure based on reports they received of a rare, but serious eye infection (Acanthamoeba keratitis) that is caused by a parasite. The connection between the infection and the solution was identified by an investigation led by the Centers for Disease Control and Prevention (CDC).
Consumers that wear soft contact lenses should cease using the solution, discard any used or unopened bottles and replace their lens storage container.
Acanthamoeba keratitis can lead to vision loss that may require a corneal transplant in some patients. The infection primarily affects otherwise healthy people that happen to wear contact lenses.
“We believe the company acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “FDA and CDC are working closely with the company to collect additional information and we will continue to alert consumers and advise them as more information becomes available.”
“The ongoing CDC investigation is a collaborative effort,” said Michael Beach, M.D., a Division of Parasitic Diseases team leader with CDC. “We are working with FDA, state, territory, university, and clinical partners in an effort to further understand whether usage or contamination of this solution led to these Acanthamoeba infections.”