Advisory
2007-61
May 30, 2007
For immediate release
OTTAWA - Health Canada is advising patients who wear soft contact lenses about a recall of COMPLETE All-In-One Contact Lens Care Solution, because of reports in the United States of a rare, but serious, eye infection. The product in Canada, COMPLETE All-In-One Contact Lens Care Solution, bears a different name than the product marketed in the U.S.
A link between the solution and the infection, acanthamoeba keratitis, caused by a parasite, was identified as a result of an investigation by the U.S. Centers for Disease Control and Prevention (CDC). The U.S. Food and Drug Administration has also issued a news release, recommending that consumers stop using the solution and discard all partially used or unopened bottles and replace their lenses and storage container.
The symptoms of acantamoeba keratitis infections may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing. Acanthamoeba keratitis may lead to vision loss, with some patients requiring a corneal transplant. Consumers should seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment.
The Drug Identification Number (DIN) for this product is 02034425. The DIN can be found on the front panel of the product label and outer packaging.
The manufacturer, Advanced Medical Optics, is recalling the product as a precautionary measure. Health Canada continues to monitor the effectiveness of this recall.
Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To date, there have been no cases of acanthamoeba keratitis linked to the use of this product reported in Canada. To report a suspected adverse reaction to this or any other health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:
Telephone: 1-866-234-2345Facsimile: 1-866-678-6789
CADRMP
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
email: cadrmp@hc-sc.gc.ca
The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located on the MedEffect portal of the Health Canada Web site.
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Media Inquiries:
Alastair Sinclair
Health Canada
(613) 957-1803
Public Inquiries:
(613) 957-2991
1-866 225-0709
