The Food and Drug Administration (FDA) in the United States has issued a warning to health care professionals and consumers regarding a certain contact lens solution.
The solution, Complete MoisturePlus Multi Purpose, has been linked to a rare but serious eye infection, Acanthamoeba keratitis, which is caused by a parasite, which can lead to vision loss with some patients needing a corneal transplant.
The infection affects otherwise healthy people who wear contact lenses and 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).
After interviewing 46 patients with Acanthamoeba keratitis, the CDC found that of the 39 who wore soft contact lenses, 21 used Complete MoisturePlus.
It is estimated that Acanthamoeba keratitis infections usually occur in approximately 2 out of every 1 million contact lens users in the United States each year.
The symptoms are 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 is much more difficult to treat.
The FDA is now advising those who wear soft contact lenses to stop using the solution and to discard all partially-used or unopened bottles; they are also advising consumers to replace their lenses and storage containers.
The manufacturer of Complete MoisturePlus, Advanced Medical Optics (AMO), has recalled and stopped shipments of the contact lens solution after data from the CDC has estimated that the risk of infection is at least seven times greater among users of the solution compared with those who did not.
AMO says patient safety is a top priority and the company is urging consumers to discontinue the use of AMO Complete MoisturePlus until further information is available.
AMO says there is no evidence to suggest that the recall is related to product contamination and is cooperating with the CDC and the U.S. Food and Drug Administration in assessing the data.
Consumers are advised to check with their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment.
Last year Bausch & Lomb were also forced to recall its contact lens solution after it was linked to Acanthamoeba keratitis.
The FDA has issued advice to all contact lens users on the measures to be taken to avoid eye infections which can be found on http://www.fda.gov/medwatch/report.htm and additional information about Acanthamoeba infection is available from the CDC website at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm.