Three brands of carbomer eye gel recalled

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

An MHRA notice highlights that specific batches of AaCarb, Aacomer and Puroptics eye gel distributed after August 2023 are being recalled. The eye gel brands are manufactured by Indiana Ophthalmics and distributed by Trion Pharma, Essential-Healthcare and Biovantic Pharma, respectively.

Details of the affected lots and serial numbers and product code are included in the full release online.

Practitioners are advised to stop supplying the above products to customers or patients, and ask customers and patients to return affected products. A poster notifying customers of the issue is 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.

Explaining the potential risk associated with these products, the MHRA highlighted: “There is a potential risk of contamination of specific brands of carbomer eye gels with a type of bacteria called Burkholderia cenocepacia.”

“An investigation by the UK Health Security Agency (UKHSA) has identified a potential association with these specific eye gels. Investigation and testing are still ongoing and these eye gels are being recalled as a precaution,” the MHRA explained.

The UKHSA considers that the risk to the general public is low from this type of bacteria. However, some patient groups, such as those with cystic fibrosis, are at a higher risk of adverse effects.

“As a precautionary measure until further information is available, UKHSA has recommended that all carbomer containing eye gels are avoided where possible in individuals with cystic fibrosis; patients being cared for in critical care settings (e.g. intensive care), or who are severely immunocompromised and in hospital, and for patients awaiting lung transplantation,” the MHRA highlighted.

AOP clinical and professional director, Dr Peter Hampson, 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,” he said.

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.

AOP members with questions about the recall can contact the regulation team by email.

UK Health Security Agency investigating 20 cases of bacterial infection

Dr James Elston, UKHSA public health consultant, confirmed that 20 patients have contracted this strain of Burkholderia cenocepacia since the start of 2023, with the majority from October onwards.

“The source has not yet been confirmed, but along with MHRA we are currently looking into carbomer containing lubricating eye gels,” he said.

The UKHSA highlighted that while preliminary findings suggest a common link to a carbomer containing lubricating eye gel, the investigation is ongoing and confirmatory testing has not yet been conclusive. No deaths are known to be associated with the outbreak.

“As a precautionary measure, we have provided additional recommendations about the use of these types of products for some individuals, who might be at higher risk of becoming unwell from infection with Burkholderia cenocepacia. UKHSA continues to work with the NHS and MHRA to assess and address risks to ensure patient safety,” Elston shared.