Advisory

2007-144
October 5, 2007
For immediate release

Update on recall of COMPLETE All-In-One Contact Lens Care Solution

OTTAWA - Health Canada is reminding consumers who wear soft contact lenses about the recall of COMPLETE All-In-One Contact Lens Care Solution. Adverse reaction reports to Health Canada of potentially serious eye problems since the recall was announced May 30, 2007 suggest that consumers may still be using the product.

COMPLETE All-In-One Contact Lens Care Solution, manufactured by Advanced Medical Optics, was recalled in Canada after the U.S. Centers for Disease Control and Prevention (CDC) identified an association between the solution and the infection, acanthamoeba keratitis. Health Canada issued a Public Advisory on May 30, 2007, recommending that consumers stop using the solution and discard all partially used or unopened bottles and replace their lenses and storage container. The product in Canada, COMPLETE All-In-One Contact Lens Care Solution, bears a different name than the product marketed in the U.S.

The symptoms of acanthamoeba 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, and some patients require 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.

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 report a suspected adverse reaction to this product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
CADRMP
Marketed Health Products Directorate
Ottawa, ON, AL 0701C
K1A 0K9
E-mail: 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 area of the Health Canada Web site.

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Media Enquiries:
Alastair Sinclair
Health Canada
(613) 957-1803

Public Enquiries:
(613) 957-2991
1-866 225-0709