Device safety informationMHRA
EyeCee One and EyeCee One Crystal preloaded intraocular lenses (IOLs) safety warning over a safety concern
The MHRA is providing an update on the issue of increased intraocular pressure in patients implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses.
What to do now
The MHRA has published safety information about EyeCee One and EyeCee One Crystal preloaded intraocular lenses (IOLs).
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2023/007). Quoted as issued.
Summary
The MHRA is providing an update on the issue of increased intraocular pressure in patients implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses.
The risk
Devices Details Device Name: EyeCee One and EyeCee One Crystal preloaded intraocular lenses (IOLs) Affected lot numbers/serial numbers: see Field Safety Notice
Advice for healthcare professionals
Identify the IOLs affected by the updated Field Safety Notice and follow the actions in the notice to retain these for manufacturer recall
All other EyeCee One and EyeCee One Crystal preloaded IOLs within their expiry date can now be used.
There are specific reporting arrangements for healthcare professionals to follow in each region. Healthcare professionals should report incidents:
in England and Wales to the Yellow Card scheme or via the Yellow Card app
in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
in Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system
Actions for patients
The advice in this notice is aimed at the healthcare teams who are responsible for providing and monitoring lenses used in cataract surgery. If you or somebody in your care had cataract surgery recently and are concerned, please contact the hospital where you had surgery for advice.
If you received one of the affected EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs) you should have had your eye pressures checked in February 2023, as advised by NatPSA/2023/003/MHRA :
If your intraocular pressure was found to be normal, you do not need to have additional monitoring. You should continue to attend your normal recommended sight tests with your optometrist at least every 2 years.
If your intraocular pressure was found to be high, continue to attend appointments with the specialist for treatment and monitoring.
Patients and caregivers in the UK can report suspected adverse reactions to medical devices to the Yellow Card scheme .
Advice for patients
Patients who were found to have normal intraocular pressure do not require further follow-up, as the increased pressure occurs in the period covered by general postoperative management after cataract surgery. They should continue to have regular sight tests with their optometrist. Patients who were found to have high intraocular pressure should continue to be seen by an appropriate specialist for treatment and monitoring.
Open the MHRA notice
Questions
Why has EyeCee One and EyeCee One Crystal preloaded intraocular lenses (IOLs) been recalled?
The MHRA has published safety information about EyeCee One and EyeCee One Crystal preloaded intraocular lenses (IOLs). Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.