Warning
2007-23
March 12, 2007
OTTAWA - Health Canada is warning consumers not to use Lots GC6038 and GC6052 of the product ReNu MultiPlus contact lens solution because they contain higher than expected amounts of iron that could reduce the product’s effectiveness and cause serious eye injury from infection. A recall of the affected lots from wholesalers, retailers, distributors and eye care professionals has been initiated by the manufacturer, Bausch and Lomb.
ReNu MultiPlus is used for the cleansing, rinsing and storage of soft contact lenses. Bausch and Lomb has advised Health Canada that it began an investigation into the product after receiving three customer reports of discoloured solution. This discolouration is caused by higher than expected levels of iron, and indicates that the solution may be losing effectiveness.
People who used the affected lots and experience symptoms of eye infection such as redness, swelling, discharge, pain, itchiness, increased sensitivity to light or change in vision should seek medical attention.
The affected lots were packaged in ReNu MultiPlus Club Packs and ReNu MultiPlus Vision Packs, each of which contain two 480 mL bottles of solution. Lot numbers can usually be found on the front panel of the bottle. If any bottle of this product has either of the Lot numbers GC6052 or GC6038, then it is part of this recall and consumers should immediately stop using the product and either dispose of it or contact the Bausch and Lomb consumer affairs line (1-866-259-8255) to arrange for a replacement. However, consumers should not discard these products until they have received guidance from their Municipal Government regarding their safe disposal. The Drug Identification Number (DIN) for this product is 02230538. The DIN can be found on the front panel of the product label and outer packaging.
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 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.
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Media Enquiries:
Health Canada
(613) 957-2983
Public Enquiries:(613) 957-29911-866 225-0709
