3 August 2023
The MHRA (The Medicines and Healthcare Products Regulatory Agency) has recently issued a patient safety alert in respect of the EyeCee One preloaded and EyeCee One Crystal preloaded Intraocular lenses which were made between September 2021 and November 2022. These lenses can be used during cataract surgery.
The patient safety alert is further to it being 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. Raised intraocular pressure in the eyes, if left untreated, can result in vision loss.
A report was released by the manufacturer, Nidek, on 13 July 2023, a copy of which can be accessed on the following link, confirming the recall of EyeCee One preloaded and EyeCee One Crystal preloaded:
Medicines and Healthcare products Regulatory Agency (filecamp.com)
The MHRA alert requires that all patients who have been implanted with the above lenses since 1 October 2022 be contacted by telephone by their cataract provider to advise them to have the pressure in their eye/s tested (within 2 weeks of notification). This is for both NHS and private provisors of cataract care.
It is noted that around 20 NHS trusts have suspended the use of the EyeCee One Lenses, including the Hull University Teaching Hospitals NHS Trust and the Royal Wolverhampton NHS Trust. The Hull Trust alone have contacted approximately 1,000 patients and invited them to urgently get their eyes checked after the MHRA warned of the links to higher pressure in the eye, which can cause loss of vision.
Steps that should be taken by the Cataract Provider
- Where the patient has received this care privately the default expectation is that this follow-up will be provided by the private provider
- Where a patient has received NHS-funded care this follow-up will be provided by the secondary care provider if the person is ineligible for an NHS-funded sight test in primary care i.e., the patient is aged less than 60 years old.
- All other patients may present in primary care for this follow-up to be completed if they are unable to be seen in secondary care.
- The MHRA alert also notes that affected patients who are not being followed up by their cataract provider should be provided with a letter to take to their local optometrist confirming that they have been implanted with the affected devices.
- This communication should also include details of how to inform the secondary care provider of the results of the test and a named contact should urgent referral be required.
It is estimated that between 2 and 4 percent of patients could have complications. However, the MHRA has stressed that reduced vision would only occur if patients were not treated. It is therefore very important that, if you have had one of the lenses implanted, you have your pressure levels in your eyes checked and if you do have raised intraocular pressure, you are referred for urgent treatment.
Williamsons would like to spread awareness of this alert and urge patients who have not been recalled, or if they are suffering with severe pressure and other associated symptoms in their eyes following their cataract operation, to go back to their cataract provider to make urgent contact with them as soon as possible.
If you have suffered injury as a result of the defective lenses, you may be able to bring a claim for clinical negligence. When undergoing cataract surgery, you do so in the hope of improving your vision and if the opposite occurs, it can have devastating consequences for the individual and their quality of life.
At Williamsons Solicitors, we have the skills, knowledge and a dedicated Clinical Negligence Team with vast experience within substandard optical care. We are dedicated to helping our clients, with the care, compassion and understanding that is needed when dealing with life-changing injuries.
If you or someone you know has been impacted by the Defective EyeCee one Lenses, please contact our experienced team, on 01482 323697, to discuss how we may be able to assist.
