本文发表在 rolia.net 枫下论坛Recall of COMPLETE All-In-One Contact Lens Care
Solution 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: 1-866-234-2345
Facsimile: 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.
Get news delivered with the All new Yahoo! Mail. Enjoy RSS feeds
right on your Mail page. Start today at
http://mrd.mail.yahoo.com/try_beta?.intl=ca更多精彩文章及讨论，请光临枫下论坛 rolia.net
Solution 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: 1-866-234-2345
Facsimile: 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.
Get news delivered with the All new Yahoo! Mail. Enjoy RSS feeds
right on your Mail page. Start today at
http://mrd.mail.yahoo.com/try_beta?.intl=ca更多精彩文章及讨论，请光临枫下论坛 rolia.net