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Total1 and total30 contact lenses

Official notice

3 Sept 2024

Last checked

3 Sept 2024

Critical riskHealth Canada

An official Health Canada notice concerns Total1 and total30 contact lenses. 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 Published 2024-09-03.

What to do now

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

Recall number

75969

Official notice

2024-09-03

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

please

Recall Numbers

75969

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Affected products

Product 1

Affected products - Total30 (Lehfilcon A) Soft Contact Lenses, Lot or serial number - See manufacturer’s website, Model or catalogue number - 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

Product 2

Affected products - Soft Contact Lens delefilcon A Multifocal, Lot or serial number - See manufacturer’s website, Model or catalogue number - 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

Product 3

Affected products - Dailies Total1 One-Day Contact Lenses For Astigmatism, Lot or serial number - See manufacturer’s website, Model or catalogue number - 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

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Alcon Laboratories, Total1 And Total30 Contact Lenses.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

75969

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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