Advice for patients following cataract surgery with EyeCee One Lenses

We are acting on behalf of patients who received EyeCee One lenses as part of their eye surgery. The Medicines and Healthcare Products Regulatory Agency (MHRA) raised safety concerns related to a product used in cataract surgery and there has subsequently been a recall on lots of Eyecee One / Eycee One Crystal preloaded lenses made between September 2021 and November 2022

The manufacturers report that following their own investigation , they have discovered that there is a problem with these lenses in that a coating used in the injector used to help administer the lens has been found to obstruct the natural drainage pathways in the eye which is typically resulting in an increase in pressure in the eye known as raised intraocular pressure (IOP).This can result in permanent damage of the eye and if untreated, loss of vision7. A number of patients who received EyeCee One Lenses have contacting us for help and guidance about what they can do. If you have been affected you can contact us for a free initial chat to talk through your options.

What action has been taken in relation to EyeCee One Lenses safety concerns?

As well as recalling these defective lenses in the field safety notice issued n 13^th July; around 20 Trusts are believed to have suspended the use of the product, and the MHRA has instructed trusts to recall patients who have had surgery since October 2022 stating that between 2% and 4% of patients could have complications.

The field safety notice issued by the manufacturer Nidek on 13 July 2023 said that there use of the affected lots of lens could result in sustained  elevated pressure in the eye and that patients implanted with one of the lenses should monitored and any signs of raised IOP referred for urgent treatment.

How can patients be affected by defective EyeCee One Lenses?

The MHRA has also stated that reduced vision would only occur if patients were not treated and that complications could be due to a coating used on the injector used to administer the lenses which could have serious impacts if not treated.

The patient safety alert issued by the MHRA in January 2023 gave Trusts two weeks to contact patients for further tests and set up a rapid access pathway for those with higher pressure.

One of the Trusts using the product, Hull University Teaching Hospitals Trust, is inviting around 1,000 affected patients for checks. The latest Field Safety notice requires all affected lots to be returned to the manufacturer.

NHS England previously indicated that ‘a minority of NHS Trusts have suspended the use of EyeCee One lenses used for cataract surgery, while any patient who has had surgery involving these products in recent months will be contacted by their clinician for an assessment – but it is expected that only a fraction will need further treatment’. Whether this suspension continues for non-affected lots remains to be seen.

 

Can I make a legal claim if I have been impacted by defective EyeCee One Lenses?

If you have been impacted by defective EyeCee One lenses, you are well within your rights to speak to an expert about your rights to pursue a claim. Contact our medical negligence team who have extensive experience in pursuing claims for defective medical equipment.  We’re already supporting patients directly impacted and have successfully settled cases for other complicated Group Actions. We have the skills and experience to guide you through the process, and keep you updated along the way – with no upfront costs to you. For added reassurance we usually fund these cases through a No Win, No Fee agreement which means there would be no financial risk to you and if we lose there is nothing to pay.

Christian Beadell, Head of Group Actions within the medical negligence team at Fletchers, said: “We are urgently investigating the circumstances of this recall on behalf of our clients who has been recalled for an urgent review.

“They are understandably very anxious about the reports of increased pressure in the eye, and that this procedure could affect their sight.

“It is extremely troubling that either the use of this product or the product itself could have such severe consequences. We welcome the swift and forthright action of the manufacturers in seeking a recall of the affected batches”

What is a Group Action?

A Group Action is a collective legal case whereby the individual parties affected by a single incident – which may be the negligent actions of a particular surgeon or medical professional, or the negligent processes within a specific NHS Trust – are represented collectively by a specialist team.

We have successfully managed Group Actions for a number of years and have recently recovered more than £1,000,000 in compensation for one Group Action alone. We have a dedicated team committed to managing Group Action cases, which means you will be supported by a specialist group of experts who know the case inside out.

How to join our Group Action and access support

It takes just one call to see if we are able to help. The National patient safety alert advises that all clinics are in the process of contacting people who have been affected and will be arranging an IOP assessment. The recalled IOLs have been used in around 5% of procedures in the UK in the last four months so many people will be completely unaffected. However, 100s of people have been negatively impacted and if you have experienced any eye symptoms, from minor discomfort and pain to serious issues with vision – we’d recommend seeking medical advice straight away, and that you get in touch with us for advice about whether you have a claim and are entitled to compensation, and register your interest in joining our group action.

Call our expert medical negligence team on 0330 013 0251, or Contact Us at enquiry@fs.co.uk. Our specialist team will support you throughout the lifetime of your case, and keep you informed every step of the way.