Contact Lens Solution Recall: Serious Eye Infection Risk
Contact lens wearers should immediately stop using Complete MoisturePlus Multi Purpose Solution and discard all partially-used or unopened bottles. Reports of a rare and extremely serious eye infection have been linked to the solution. The infection, Acanthamoeba keratitis, is caused by a parasite and may lead to vision loss with some patients requiring a corneal transplant. Normally healthy people who wear contact lenses may be affected by the parasite. During a recent investigation by the Centers for Disease Control (CDC), users of the Complete MoisturePlus Multi Purpose Solution were at least seven times more likely to develop Acanthamoeba keratitis than those who used another brand.
According to an announcement by the director of the Center for Devices and Radiological Health of U.S. Food and Drug Administration(FDA), the manufacturer of the product, Advanced Medical Optics, "acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public 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."
Consumers should consult with their doctors about alternative cleansing/disinfecting products. If they have any symptoms of eye infection, they should seek immediate medical attention. Early detection is critical for effective treatment of Acanthamoeba keratitis.
To help prevent eye infections, all contact users should follow these safety guidelines:
- Remove contact lenses before any activity involving contact with water.
- Wash hands thoroughly before handling contact lenses.
- Clean contact lenses according to instructions from manufacturer and ye care professional.
- Use fresh cleaning solution each time lenses are cleaned.
- Never reuse or top off any old solution.
- Never substitute saline solutions or rewetting drops to disinfect lenses.
- Schedule regular eye exams with your eye care professional.
- Wear and replace contact lenses as prescribed by your eye doctor.
- Store lenses in proper storage cases.
- Storage cases should be irrigated with sterile contact lens solution.
- Storage cases should be left open to dry after each use.
- Replace storage cases at least once every three months.
To report any adverse events related to use of Complete MoisturePlus products, contact MedWatch, the FDA's voluntary reporting program, by any of the following methods:
Phone: (800) 332-1088
Fax: (800) 332-0148
Mail: Medwatch, Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787
Additional information about Acanthamoeba keratitus (AK) is available at the CDC website.