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Health Canada Medical devices

Total1 and Total30 Contact Lenses

Issued September 3, 2024
Issue
Alcon has initiated a Voluntary Medical Device Field Correction for specific lots of DAILIES TOTAL1® for Astigmatism, DAILIES TOTAL1® Multifocal and TOTAL30® Sphere contact lenses. An isolated quality issue was identified with a material supplied by a third-party vendor that was used in the production of contact lenses at a single manufacturing site. As a result, the affected lenses may not meet Alcon quality and/or performance standards for the entirety of their labeled shelf life. The contact lenses from the identified lots are not expected to cause an increased risk to the wearer. As with any contact lens, there is a remote likelihood that wearing a lens from the affected lots may lead to temporary issues such as irritation, redness, or blurred vision. These symptoms typically resolve after lens removal and/or replacement (as directed in the patient leaflet1). You can confirm if a lot number of contact lenses is within the scope of the medical device recall at https://www.myalcon.com/search-my-lot/ . If you have an affected lot number, please discontinue use of the product and contact your eye care provider or the retailer where you purchased the contact lenses for further information on next steps. Recall start date: August 13, 2024
Hazard description
Performance
Product
Product name
Total1 and Total30 Contact Lenses
Reference
ID
RA-75969