One person has died and many others have become infected after using contaminated gel to treat dry eye disease in the UK, a government report has revealed.

The UK Health and Safety Agency (UKHSA) is investigating an outbreak of Burkholderia cepacia complex (Bcc) linked to a specific brand of lubricating eye gel.

A Health Protection report said there were 52 confirmed cases and six suspected cases linked to the outbreak across the UK between January 2023 and February 2024.

Of those, 25 were thought to have “clinically significant infections attributable to BCC,” including 11 with eye infections, nine with respiratory infections and four with bacteremia (bacteria entering the bloodstream).

Two cystic fibrosis patients became infected, one while receiving treatment, and the other died, with the report finding that Bcc infection “is believed to have contributed to the death of one case.”

Of all those affected, the youngest was an infant and the oldest was 91 years old.

Seven of 10 cases (71%) were hospitalized, with 38 requiring intensive care.

Bcc is widely found in the environment, including soil and water, and is naturally resistant to many antibiotics, the report said.

Safety instructions

It added that BCC “rarely causes infection” in healthy people but can cause serious infections in people with weakened immune systems and people with cystic fibrosis.

In November last year, the medicines regulator the Medicines and Healthcare products Regulatory Agency (MHRA) issued a safety notification for certain batches of carbomer-containing gel “due to the possibility of microbial contamination”.

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At the time, certain batches of three eye gels were recalled: AaCarb, Aacomer and Puroptics.

Charity Cystic Fibrosis Trust has since urged people not to use the withdrawn products.

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The MHRA said it had now “obtained adequate assurances from manufacturers and suppliers to conclude that the products on the UK market are safe for use and are not contaminated”.

The Cystic Fibrosis Trust has now said: “All patients can now use lubricating eye products containing carbomer, except for recalled products.”

The Health Protection report said: “UK HSE will continue to track new cases and remain alert to emerging Burkholderia cepacia strains.”

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