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IRIC safety alert

MHRA Medical Device Safety Information – MDSI2311U

Published on 03 April 2024

From: Health Facilities Scotland

MDSI2311U - Specific brands of carbomer eye gel: recall of AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel: potential risk of infection - UPDATE



The Medicines and Healthcare products Regulatory Agency (MHRA) has updated the webpage on which MDSI2311 was based and which was published on 24 November 2023. The MHRA has issued the following update: The Medicines and Healthcare products Regulatory Agency (MHRA) are satisfied that carbomer-containing lubricating eye products available on the UK market are safe to use. Therefore, the action to ‘avoid the use of all carbomer-containing eye products in individuals with cystic fibrosis, patients being cared for in critical care settings, the severely immunocompromised and patients awaiting lung transplantation’ has been removed. All patients can now use carbomer-containing lubricating eye products, with the exception of the recalled products. The other recommendations within the DSI remain.