| Date Recall Initiated |
May 25, 2007 |
|---|---|
| Product: |
COMPLETE ® MoisturePLUS ™ Multi-purpose Contact Lens Solution 14 U.S. Product Brands distributed under the Complete ® MoisturePLUS ™ Multi-purpose Contact Lens Solution (formual 9451x):
AMO has 486 U.S. accounts and distributed 57,252,581 units worldwide (27,807,198 units in the U.S.) from May 25, 2005 through May 28, 2007. |
| Use: |
The solution cleans and disinfects soft contact lenses. |
| Recalling Firm: |
Advanced Medical Optics, Inc. 1700 E Saint Andrew Place Santa Ana, California 92705-4933 |
| Reason for Recall: |
There is a recent increase of a rare but serious infection in people who wear soft contact lenses. The infection is Acanthamoeba keratitis, caused by a parasite that is commonly found in nature. Acanthamoeba keratitis can cause permanent damage to the cornea and loss of vision. Some patients may require a corneal transplant, a surgical procedure that replaces the clear outer covering of the eye, in order to maintain vision in the affected eye. Early diagnosis and treatment of Acanthamoeba keratitis is important to prevent permanent damage of the cornea. The U.S. Centers for Disease Control and Prevention found an association between this type of infection and the use of Complete® MoisturePLUS™ Multi-purpose Contact Lens Solution; although at present nothing suggests that the product is contaminated with the Acanthamoeba parasite. |
Public Contact: |
Consumers can call the company’s hotline at 1-888-899-9183 or visit their website at www.amo-inc.com for instructions on what to do with their unused solution or unopened bottles. |
| FDA District: |
Los Angeles |
| FDA Comments: |
On May 25, 2007, Advanced Medical Optics (AMO) issued a press release announcing the voluntary recall of its Complete® MoisturePLUS™ Multi-purpose Contact Lens Solution from the market. AMO sent information on this recall to corporate accounts and eye care professionals. The following are recommendations for users of Complete® MoisturePLUS™ Multi-purpose Contact Lens Solution
Consumers can read additional FDA Information related to this recall by visiting:
More information about contact lenses and eye care can be found at http://www.fda.gov/cdrh/contactlenses/. If you have any concerns about your contact lenses, you should contact your eye care professional. Additional information about Acanthamoeba infection is available from the CDC website at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
|
Updated August 1, 2007
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