Carbomer eye gel recall on specific brands

The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled three brands of carbomer eye gel over concerns about a possible risk of infection.

The MHRA notice highlights that specific batches of AaCarb, Aacomer and Puroptics eye gel distributed after August 2023 are being recalled due to the potential risk of contamination with the Burkholderia cenocepacia bacteria.

Members are advised to stop supplying the products to customers or patients, and ask customers and patients to return affected products.

The full details of affected lots and serial numbers and product code is included in the MHRA alert. A poster notifying customers of the issue is also available to download within the MHRA release.

For high-risk patients, practitioners should stop supplying any brand of carbomer eye gel as a precaution – not just the brands subject to the recall.

The UK Health Security Agency (UKHSA) has also recommended, as a precautionary measure, that all carbomer containing eye gels are avoided where possible in individuals with cystic fibrosis; patients being cared for in critical care settings (eg intensive care), or who are severely immunocompromised and in hospital, and for patients awaiting lung transplantation.

Dr Peter Hampson, AOP Clinical and Professional Director, highlighted that optometrists should not recommend any carbomer gels to patients in high-risk groups.

“In addition, they need to be vigilant for any unusual signs or symptoms in patients using carbomer gel. If optometrists are aware that they have provided a product subject to the recall to a patient in a high-risk group, they should contact the patient to ask them to return the potentially affected product.”

The eye gel brands are manufactured by Indiana Ophthalmics and distributed by Trion Pharma, Essential-Healthcare and Biovantic Pharma.

Members with questions about the recall can contact the regulation team: [email protected]