Contact Lens Solution Recall Advice
FDA, CDC Tell Consumers What to Do to Limit Their Risk of Eye Infection
May 30, 2007 -- Advanced Medical Optics has voluntarily recalled its Complete MoisturePlus multipurpose solution for contact lenses.
The recall is due to concerns about a rare but serious eye infection called Acanthamoeba keratitis, which is caused by a waterborne parasite.
In a news release dated May 25, Advanced Medical Optics states that "there is no evidence" of a product contamination issue. The recall doesn't include the company's other products.
The CDC and FDA have this advice for consumers:
- Stop using the recalled solution and discard all remaining solution.
- Choose an alternative contact lens solution. Consult your eye care provider for help.
- Replace your lenses and storage container.
- Seek immediate treatment if you have any signs of eye infection.
Acanthamoeba keratitis is caused by a microscopic amoeba that is relatively common in the environment, according to the CDC. Most people will be exposed to Acanthamoeba during their lifetime and not get sick. However, Acanthamoeba is capable of causing several infections in humans.
The symptoms of Acanthamoeba keratitis can be very similar to those of other, more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye, or excessive tearing. But Acanthamoeba keratitis is harder to treat.
Acanthamoeba keratitis, which mainly affects healthy contact lens wearers, may lead to vision loss, with some patients requiring a corneal transplant. Early treatment is important for effective treatment.
The recall stems from CDC interviews of 46 people who developed Acanthamoeba keratitis since 2005. Those patients included 39 contact lens wearers, 21 of whom reported any use of Complete MoisturePlus multipurpose cleaning solution in the month before their symptoms started.
The CDC estimates that of the patients interviewed, the risk of developing Acanthamoeba keratitis was seven times greater for users of Complete MoisturePlus multipurpose solution than those who didn't use that product.
Advanced Medical Optics states that it is "fully cooperating with the CDC and FDA" and issued the recall "out of an abundance of caution."
In an FDA news release, the FDA's Daniel Schultz, MD, says the FDA believes that the company "acted responsibly" in issuing the recall.
Schultz directs the FDA's Center for Devices and Radiological Health.