Health product recall

Total1 and Total30 Contact Lenses

Last updated

Summary

Product
Total1 and Total30 Contact Lenses
Issue
Medical devices - Performance
What to do

If affected, stop use and contact your eye care provider or retailer for guidance on next steps.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Total30 (Lehfilcon A) Soft Contact Lenses

See manufacturer’s website

30004013+02.50D
30004013-03.50D
30004013-04.75D
30004013-05.75D
30004013-02.75D
30004013-04.25D
30004013-05.25D
30004013-06.00D
30004013-1.50D
30004013-00.75D
30004013-02.50D
30004013+03.00D
30004013-01.25D
30004013-02.25D
30004013-03.25D
30004013-04.00D
30004013-04.50D
30004013-08.50D
30004013-01.00D
30004013-02.00D
30004013-05.00D

Soft Contact Lens delefilcon A Multifocal

See manufacturer’s website

30003623+00.25D
30003625-01.25D
30003625-02.75D
30003623+01.75D
30003624-08.50D
30003625+01.75D
30003625+02.25D
30003625-05.50D
30003625-06.50D
30003623+03.75D
30003623+04.00D
30003623-06.00D
30003625+01.25D
30003625+02.00D
30003625-02.25D
30003625-04.00D
30003625-05.00D
30003625-08.00D
30003623+03.25D
30003623-03.00D
30003623-08.50D
30003625+01.50D
30003625+02.50D
30003625+03.00D
30003625-01.00D
30003625-02.00D
30003625-02.50D
30003623-01.25D
30003625-04.25D
30003623-05.00D
30003625-05.25D
30003623-00.50D
30003625-00.75D
30003625-03.75D
30003625-04.50D

Dailies Total1 One-Day Contact Lenses For Astigmatism

See manufacturer’s website

900263595-00.75D
900263595-01.75D
30003964+01.75D
900263595+02.50D
900263595-02.75D
900263595-03.00D
900263595+00.75D
900263595+01.50D
900263595-00.50D
900263595-02.25D
900263595-05.00D
900263595-06.00D
900263595-06.50D
30003964-00.50D
900263595+01.00D
900263595-05.50D
30003964-00.25D
30003964-03.75D
900263595-03.50D
900263595-01.50D
900263595-04.25D
900263595-04.50D
900263595-04.75D
30003964-01.75D
30003964-03.00D
900263595+03.50D
900263595+04.00D
900263595-03.75D

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - Ophthalmology
Companies
Alcon Laboratories Inc.
6201 South Freeway, Fort Worth, Texas, United States, 76134-2099
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75969

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