Complete MoisturePlus Solution - Recall and Health Information - FindLaw
Created by FindLaw's team of legal writers and editors| Last reviewed January 28, 2013
On May 26, 2007 the U.S. Food and Drug Administration (FDA) issued an alert to health care professionals and their patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution manufactured by Advanced Medical Optics of Santa Ana, Ca. The recall was initiated because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC).
Acanthamoeba keratitis may lead to vision loss, and may eventually require a corneal transplant for some patients. The infection primarily affects otherwise healthy people who wear contact lenses. According to the FDA, Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. However, in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, CDC determined that the risk of developing AK was at least seven times greater for those consumers who used Complete MoisturePlus solution versus those who did not.
Advice for Consumers
The FDA is advising consumers who wear soft contact lenses to stop using Complete MoisturePlus solution, discard all partially-used or unopened bottles and replace their lenses and storage container.
All contact lens users should closely adhere to the following measures to help prevent eye infections:
- Remove contact lenses before any activity involving contact with water, including showering, using a hot tub, or swimming.
- Wash hands with soap and water and dry them before handling contact lenses.
- Clean contact lenses according to manufacturer guidelines and instructions from an eye care professional.
- Use fresh cleaning or disinfecting solution each time lenses are cleaned and stored. Never reuse or top off old solution.
- Never use saline solution and rewetting drops to disinfect lenses. Neither solution is an effective or approved disinfectant.
- Schedule regular eye exams with your eye care professional
- Wear and replace contact lenses according to the schedule prescribed by your eye care professional.
- Store lenses in a proper storage case.
- Storage cases should be irrigated with sterile contact lens solution (never use tap water) and left open to dry after each use.
- Replace storage cases at least once every three months.
According to an announcement on the Advanced Medical Optics company website, consumers who believe they are in possession of the recalled lens solution should discontinue use immediately and call 1-888-899-9183. Advanced Medical Optics will continue to provide businesses and customers with information and instructions for return and replacement of the product.