Our team of experts will support you all the way
-
Christian Beadell
Head of Group Actions
-
Francesca Paul
Associate
Published: August 25, 2023 | Last Updated: September 20, 2023
We are acting on behalf of a group 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 / EyeCee One Crystal preloaded lenses made between September 2021 and November 2022.
This has resulted in a serious impact on many people including some who are already our clients. Our client was featured by the BBC News highlighting their issue and the impacts on their life following the surgery. You can view the EyeCee BBC article here.
In the manufacturer’s report produced following their own investigation, they found there is a problem with these lenses in that a coating used in the injector used to help administer the lens was found to obstruct the natural drainage pathways in the eye. This typically resulted in an increase in pressure in the eye known as raised intraocular pressure (IOP). This can result in permanent damage of the eye if untreated including loss of vision A number of patients who received EyeCee One Lenses have contacted us for help and guidance about what they can do and we are now pursuing claims on their behalf. If you have been affected, you can get in touch for a free initial chat to talk through your options.
As well as recalling these defective lenses in the field safety notice issued on 13th July; around 20 Trusts are believed to have already 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 patients who were given these lenses could suffer from sustained elevated pressure in the eye. It also said that patients implanted with these lenses should be monitored and any signs of raised IOP referred for urgent treatment. For some people it would seem that the increased IOP has had side effects relating to their sight.
The MHRA has also stated that reduced vision would only occur if patients were not treated. They said that complications could also 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.
We are aware that at least one of the Trusts using the product, Hull University Teaching Hospitals Trust, has invited around 1,000 affected patients back for checks. The latest Field Safety notice requires all affected lots to be returned to the manufacturer. We suspect that the actions in Hull will be extended wider as other trusts see the impacts of these faulty lenses.
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.
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 lenses”
A coating used in the injector used to help administer the lens has been found to obstruct the natural drainage pathways in the eye
Hull University Teaching Hospitals Trust, is inviting around 1,000 affected patients for checks
A minority of NHS Trusts have suspended the use of EyeCee One lenses used for cataract surgery
Our expert team is investigating the circumstances of the recall on behalf of our clients who have been recalled for an urgent review.
If you have received EyeCee One Lenses and are suffering complications, then you may have a claim and we are happy to have a no-obligation chat. We worked solely on a No Win, No Fee basis which means there is no financial risk to you.. Get in touch with our specialist team and they will guide you through next steps and how we can help.