01 February 2023
National patient safety alert - information for primary eye care
EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a patient safety alert after becoming aware of cases of increased intraocular pressure in people recently implanted with the following IOLs only:
- EyeCee One preloaded,
- EyeCee One Crystal preloaded.
A Field Safety Notice (FSN) has been disseminated by Nidek (Distributed by Bausch & Lomb UK Ltd) and should be followed.
What should primary eye care do?
At this stage primary eye care providers should:
- Read this National Patient Safety Alert and MHRA notification
- Advise anxious patients that plans are being put in place to review everyone who received the IOLs in question.
- Direct people who are concerned to their cataract clinic and reassure those not affected by this product.
- Record any advice given on the record card.
- Continue to see patients as you would normally - for example if somebody reports a concern, you can see them early and refer appropriately.
- This is an evolving situation so keep up to date with sector news. We will share latest developments with you in the coming weeks.
What happens next?
The MHRA has written to cataract clinics and instructed them to contact (preferably by phone) every person who has been implanted with this lens since 1 October 2022. Each clinic will make local arrangements for IOP to be assessed in every patient.
Initial reports suggest 2-4% of people fitted with this lens since October 2022 experience increased IOP.
Arrangements to check IOP may utilise primary care optometry clinics but full details of how this caseload will be managed are still to be confirmed.
IOLs implanted prior to October are not thought to be affected, and historically the lens has an established and well-published safety record. The cause and mechanism for the increase in IOP has not been identified and further investigations are ongoing. Optometrists should ensure that they follow clinical updates.
Other frequently asked questions
What should I do if a concerned patient contacts the practice?
All cataract providers that fitted these lenses are in the process of contacting people affected and will arrange an IOP assessment within the next couple of weeks. The recalled IOLs have been used in around 5% of procedures in the UK in the last four months. Please reassure patients that all clinics are working to contact everyone effected.
What should I do if I am asked to provide an IOP monitoring service for my local cataract service?
The NHS might arrange for patients to have IOP monitored in primary eye care practices and report the results following a clinical protocol. Practices who are contacted will be given more information by the cataract service making the arrangements. It is currently recommended that any patient with these IOLs who registers an IOP of over 22mmHg should be urgently referred to their local cataract service. Full clinical records must be kept in addition to the clinical findings returned to the cataract service. Each nation's health system is aware of this alert and is working with providers to arrange care for people affected, this will include people who receive eye care in their own homes.
How many clinics are affected?
We understand about 51 clinics are affected across the whole of the UK and around 6,000 to 10,000 people may have been fitted with these implants. An MHRA notice to stop implanting the device was issued last week, so the use of this implant has been paused whilst there is an investigation. In Scotland, it is a few hundred patients at two cataract centres.
Are any patient groups at an increased risk?
People who are monocular and those who have glaucoma are considered at the highest risk.
Where can I find out more information?
National Patient Safety Alert: NIDEK EyeCee One preloaded and EyeCee One Crystal preloaded Intraocular Lenses (IOLs): risk of increased intraocular pressure (NatPSA/2023/003/MHRA) - GOV.UK (www.gov.uk)
Field Safety Notice (FSN)
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