| IRIC | Incident Reporting & Investigation Centre |
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| Outlook tags | IRICSW$i0 (safety alert – general), IRICSW$i4 (national patient safety alert) |
| Reference: | NatPSA/2023/003/MHRA |
| Subject: | NIDEK EyeCee One preloaded and EyeCee One Crystal preloaded Intraocular Lenses (IOLs): risk of increased intraocular pressure |
MHRA has published the attached National Patient Safety Alert in partnership with devolved administrations. It applies across the UK and within Scotland it should be implemented by local authorities, health boards and contractors providing publicly funded health and social care services.
A PDF version of the alert is attached. You can also view a web version on the MHRA website at: https://www.gov.uk/drug-device-alerts
Onward cascade
As the nominated person for your organisation, you need to identify managers and staff in your organisation who need to know or be aware of this alert and cascade it onward to them. The cascade should include all contractors and private or independent service providers who provide affected care, staff, equipment, buildings or other services or facilities for the direct care of patients or service users.
Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:
- Medical devices (e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator)
- In vitro diagnostic devices or IVDs (e.g. blood analyser, reagent, SARS-CoV-2 test kit)
- Estates and facilities (e.g. electrical installations, window restrictors, nurse call systems)
- Social care equipment (e.g. mobile wheeled commode, powered rise and recline chair)
- Personal protective equipment or PPE (e.g. visors, FFP3 respirators, aprons)
We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/
Enquiries
If you have any enquiries in relation to this alert please email nss.iric@nhs.scot quoting the alert reference number in the message subject line, or call the IRIC Helpline 0131 275 7575. Alternatively, if you have received this message from someone in your own organisation, please direct all enquiries to them and they will liaise with IRIC as required.
Incident Reporting & Investigation Centre (IRIC)
Health Facilities Scotland
NHS National Services Scotland
Contact us:
IRIC Email nss.iric@nhs.scot
Helpline 0131 275 7575
Web https://www.nss.nhs.scot/browse/health-facilities/incidents-and-alerts
Please consider the environment before printing this email.
NHS National Services Scotland is the common name for the Common Services Agency for the Scottish Health Service. www.nhsnss.org
FAC406-195, 7D(i), Rev 5