Notice Information: - Advisory - 17/07/2012

Title:

Hydrogen Peroxide Based Contact Lens Solutions

Product:

Hydrogen Peroxide Based Contact Lens Solutions

Reference:

SN2012(09)

Manufacturer / Supplier:

Various

Target Audience:

Opticians
Pharmacies
General Practitioners
General Public

Please bring this safety notice to the attention of all who need to be aware of it.

Issue:

The Irish Medicines Board (IMB) is issuing this Safety Notice to alert opticians, pharmacists and users of the importance of following the manufacturer’s instructions for use (IFU) when using hydrogen peroxide based contact lens solutions.

Background Information / Related Documents:

The IMB advises opticians and pharmacists to ensure that they highlight to users of hydrogen peroxide based contact lens solutions, to follow the manufacturer’s IFU. When using these products, there is a potential for hydrogen peroxide to come into contact with the eye and cause burning, irritation and stinging of the eye. In general, the IFUs of hydrogen peroxide based contact lens solution products provide instructions to users to follow specific steps to neutralise the hydrogen peroxide within the solution thus avoiding eye irritation.

The IMB believe that there is potential for experienced or long term users of contact lens solutions, not to read the IFU in full and that these users may follow habitual routines when using contact lens solutions in general. If the user is not familiar with hydrogen peroxide based contact lens solutions and does not carefully follow the IFU, a potential injury to the eye(s) may occur. The IMB is advising opticians and pharmacists to highlight the importance of following the manufacturer’s IFU when prescribing and selling hydrogen peroxide based contact lens solutions to existing and new customers.

Action to be taken:

The IMB recommends that Opticians and Pharmacists:

Highlight the importance of carefully following the instructions for use (IFU) to existing and new customers of hydrogen peroxide based contact lens solutions.

The IMB recommends that users of hydrogen peroxide based contact lens solutions:

Promptly consult their eye care practitioner and discontinue use of the product in the event of irritation, excessive tearing and vision impairment particularly if these symptoms persist or escalate.

Further Information:

ENQUIRIES

If you have any enquiries relating to a specific product, please contact the manufacturer. All contact details for the manufacturer should be included on the packaging of the product.

All adverse incidents relating to a medical device should be reported to:

Human Products Monitoring Department
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail: vigilance@imb.ie
Website: www.imb.ie

Please click here to view PDF version of this Safety Notice