Specific brands of carbomer eye gel: recall of AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel: potential risk of infection, DSI/2023/11

Indiana Ophthalmics LLP is issuing an urgent Field Safety notice to inform about the potential risk of microbial contamination in Carbomer eye Gel

Product descriptions:

AACARB (distributor name: Trion Pharma)

AACOMER (distributor name: Essential-Healthcare)

PUROPTICS (distributor name: Biovantic Pharma)

Details of the affected batch:

Brief description of problem:

There is a potential risk of microbial contamination (Burkholderia cenocepacia) in the affected eye gels. This potential link with carbomer eye gel was identified during an investigation by public health authorities and the investigation is still ongoing. There is a potential risk of infection if the affected eye gel is used. The risk is higher in people with an impaired immune system.

Advice to Healthcare Professionals:

• Stop supplying the affected batches distributed after August 2023 immediately, quarantine all remaining stock and return it to the supplier using the supplier approved process. The details of supplier / distributor for each product are provided below. 
• Where possible, contact patients/customers who have been dispensed or purchased any of the affected batches and ask them to return the product.
• Healthcare professionals who are contacted for advice should consider appropriate review of patient’s health.
• 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.

Advice to Patients:

• Stop using the products from the affected batches immediately and return the product to the place of purchase.
• Contact your doctor or pharmacist for advice if required.
• If your eye symptoms worsen or you are worried about your health, contact a healthcare professional urgently. Tell them you have been using a recalled eye gel.
• If you are an individual with cystic fibrosis and have been using carbomer containing lubricating eye gel, please stop using it and contact your cystic fibrosis clinical treatment centre for advice.
• If you are an individual awaiting a lung transplant and have been using carbomer containing lubricating eye gel, please stop using it and contact your chest physician or GP for advice.

Company contacts for further information:

Contact the below concerned distributors to the return of products:

AACARB – Trion Pharma UK, Unit 7, Kimpton Business Link, 40 Kimpton Road, Sutton, Surrey SM3 9QP, UK info@trionpharma.co.uk, +447859809049

AACOMER Eye Gel – Essential Healthcare Ltd., 249 – Ongar Road, Brentwood, Essex, CM15 9DZ, UK. Info@essential-healthcare.co.uk, +441277286199

PUROPTICS Eye Gel – Biovantic Pharma Ltd., Kemp house, 160 City Road, London. EC1V 2NX, UK anir@biovanticpharma.co.uk, +447791913552

For more information:

 Contact Indiana Ophthalmics LLP, 135, 136, 137 – GIDC Estate, Wadhwan, Gujarat, India indianaophthalmics@yahoo.co.in +912752241554 / +912752243939

To access the full recall: Indiana Ophthalmic Field Safety Notice