Device safety informationMHRA
brands of carbomer eye gel safety warning over a safety concern
Specific batches of carbomer gel are being recalled as a precaution due to possible microbiological contamination.
What to do now
Brands of carbomer eye gel is the subject of an MHRA device safety notice.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2023/11). Quoted as issued.
Summary
Specific batches of carbomer gel are being recalled as a precaution due to possible
microbiological contamination.
The risk
Update: 2 April 2024 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.
Advice for healthcare professionals
Actions for healthcare professionals
Follow the actions in the FSN including stopping supply or prescription of these specific affected gels named above to all patients/customers (supplied from August to November).
Ask customers/patients to return any affected products.
If appropriate, there is a poster attached to the FSN that can be used to draw attention to the recall.
In addition, UKHSA has recommended that all carbomer containing eye gels (in other words, any carbomer containing lubricating eye gel product, not just those referred to in the FSN) 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.
Alternative products (including non-carbomer containing lubricating eye gels) are available, see Dry eye, Treatment summaries, from the BNF .
Healthcare professionals should report incidents:
in England and Wales to the Yellow Card scheme or via the Yellow Card app
in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
in Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system
Actions for all patients/customers
Stop using affected batches of the products listed in the FSN and return the product to the place of sale.
Open the MHRA notice
Questions
Why has brands of carbomer eye gel been recalled?
Brands of carbomer eye gel is the subject of an MHRA device safety notice. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.