MHRA issues safety recall for dry eye gel treatments

These carbomer-containing gels from Aacarb, Aacomer and Puroptics have been recalled due to risk of contamination. Images courtesy of MHRA.

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a recall warning for specific batches of lubricating eye gels. In a statement, the agency said gels branded Aacarb, Aacomer and Puroptics have potential risk of microbial contamination.¹ The recall has been issued “as a precaution,” the agency stated, and risk to the public is considered to be low.

The lubricating gels are typically used to relieve symptoms of dry eye disease. Patients who use the impacted products should return them to the retailer where they were purchased. Any users who experience symptoms such as ocular pain, redness in or around the eyes or reduced vision should contact their healthcare provider immediately and report both the symptoms and their usage of the recalled products.

“Whilst the risk to users is low, we are taking precautionary action,” Alison Cave, MHRA Chief Safety Officer, said. ““If you have been using these gels, and if your eye symptoms worsen or you are worried about your health, please contact your healthcare professional. Retailers should, where possible, contact patients who have been dispensed any of the affected batches and ask them to return the product.”

The MHRA said it will work alongside the UK Health Security Agency (UKHSA) to minimise risk. “We are working very closely with our colleagues at UKHSA and will issue further advice to protect patients and the public, if needed,” Cave stated. Individuals with specific risk factors, including cystic fibrosis and certain severe respiratory conditions, are at greater risk of adverse effects from Burkholderia cenocepacia, the bacteria believed to be linked to the contamination. The UKHSA recommends that patients with cystic fibrosis avoid all carbomer-containing eye gels. Any patients in intensive care settings, patients who are immunocompromised or those awaiting lung transplants should also discontinue use of the products.

Healthcare providers and patients can report cases of infection using the Yellow Card Scheme web page.

Reference

1. Specific batches of carbomer-containing lubricating eye gels branded Aacarb, Aacomer and Puroptics recalled as a precaution due to possible microbial contamination. News release. Medicines and Healthcare products Regulatory Agency. Published November 24, 2023. Accessed November 28, 2023. https://www.gov.uk/government/news/specific-batches-of-carbomer-containing-lubricating-eye-gels-branded-aacarb-aacomer-and-puroptics-recalled-as-a-precaution-due-to-possible-microbial