Safety notice - Alcon DAILIES TOTAL1® and TOTAL30® contact lenses

On 9 August 2024, the company Alcon launched a Field Safety Corrective Action for specific lots of DAILIES TOTAL1® daily contact lenses and TOTAL30® monthly contact lenses, including multifocal lenses and lenses for astigmatism.

The affected lots were made using a solvent containing an unexpected substance that remains present in the ready-to-use contact lenses. These non-compliant products can therefore no longer be used and their distribution has been suspended.

In principle, the contact lenses from the identified lots are not expected to cause increased risk to the wearer. As with any contact lens, there is a remote possibility 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 removing and/or replacing the lens (as directed in the patient leaflet).

Affected contact lens lots

Please refer to the table below. 

Actions to take

The defective lenses must not be used.

What to do:

1. Check if you have any of these lenses by looking for the lot number, which is printed on each individual lens box as shown:

2. If the lot number is included in the list below, stop using the lenses immediately and put them aside so that you do not use them by mistake.

3. Contact the retailer from whom you purchased the contact lenses immediately (optician, pharmacy, etc.). Your retailer will have been notified of the field safety corrective action issued by the manufacturer.

4. Your retailer will provide you with information on what to do next, particularly with regard to a refund or exchange.

5. If this leaves you without any contact lenses, wear your prescription glasses and contact your retailer to obtain the contact lenses you need as soon as possible.

6. Forward this information to anyone you know who might have some Dailies Total1® or Dailies Total30® contact lenses.

7. If you have already used lenses from one of the affected lots but no longer have any of the lenses left, you do not need to take any further action.

In the event of an incident

Please report any adverse events, problems or changes in the characteristics or performance of contact lenses manufactured by Alcon (including errors in use due to ergonomic characteristics) to the following address https://notifeye.alcon.com/.

Remember, any notification of a serious incident should be sent to meddevices.vigilance@ms.etat.lu.

For any other questions, please contact your medical device market surveillance authority – which, in Luxembourg, is the Division of Pharmacy and Medicines (Division de la pharmacie et des médicaments) of the Health Directorate – by email to: meddevices.vigilance@ms.etat.lu.