- Do not implant Raindrop Near Vision Inlays.
- Identify all unused stock of Raindrop Near Vision Inlays and dispose of them.
- Monitor patients who have the inlay implanted or have previously had the device explanted for the development of corneal haze. The frequency of follow up should be determined by individual patient risk assessment.
- Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
All healthcare professionals who are responsible for or who use these devices.
Deadlines for actions
Actions underway: 27 February 2019
Actions complete: 10 April 2019
The device is a corneal inlay (corneal implant) used to improve near vision.
The USA’s Food and Drug Administration (FDA) issued a safety communication informing users that implantation of this device has led to an increased occurrence of corneal haze.
The cited study shows that 75% of 150 enrolled patients developed corneal haze. In 42% of patients, the corneal haze has been present in the central region of the cornea.
There is no specific guidance regarding frequency of follow-up from the manufacturer; the clinician should assess the risk of corneal haze in individual patients.
It is unknown how many Raindrop Near Vision Inlay devices may be placed on the market in the UK.
ReVision Optics, the manufacturer of this device, ceased operations in 2018 and no contacts are available.
Due to the lack of information on the distribution of this device, the MHRA is publishing this alert as a precautionary notice.
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- A&E consultants
- A&E departments
- A&E directors
- A&E nurses
- Community hospitals
- Minor injury units
- NHS walk-in centres
- Nursing executive directors
- Operating department practitioners
- Ophthalmic nurses
- Ophthalmology departments
- Ophthalmology, directors of
- Supplies managers
- Theatre managers
- Theatre nurses
- Walk-in centres
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- Community optometrists
- Dispensing opticians
- General practitioners
- General practice managers
- General practice nurses
Establishments registered with the Care Quality Commission (CQC) (England only)
- Care homes providing nursing care (adults)
- Hospitals in the independent sector
- Independent treatment centres
- Private medical practitioners
CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2019/007 or 2018/012/017/487/001
Tel: 020 3080 6000
Devices Clinical Team, MHRA
Tel: 020 3080 7274
To report an adverse incident involving a medical device in England use the Yellow Card reporting page.
Northern Ireland Adverse Incident Centre (NIAIC)
Department of Health, Social Services and Public Safety
Tel: 0208 9052 3868
To report an adverse incident involving a medical device in Northern Ireland use the forms on the website.
Alerts in Northern Ireland are distributed via the NICAS system.
Incident Reporting and Investigation Centre (IRIC)
Health Facilities Scotland
NHS National Services Scotland
Tel: 0131 275 7575
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account.
For more information, or if you can’t access the webform, visit the website: how to report an adverse incident.
Population Healthcare Division, Welsh Government
Tel: 02920 823 624 / 02920 825 510
To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).