Medical Device Alert: 1-Day Acuvue TruEye contact lenses manufactured by Johnson & Johnson Vision Care (Ireland) (MDA/2010/093)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/093 or 2010/008/020/081/002.

Technical aspects
Ian Smith or Michelle Kelly
Medicines & Healthcare products Regulatory Agency
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7306/7145
Email: ian.smith@mhra.gsi.gov.uk or michelle.kelly@mhra.gsi.gov.uk 

Clinical aspects
Nicola Lennard
Medicines & Healthcare products Regulatory Agency
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7126
Email: nicola.lennard@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.

Further information about CAS can be found on the Central Alerting System website (external link).

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

Recall of specific product.

Lenses from affected lots can cause stinging or pain upon insertion because of higher than expected levels of decanoic acid.

The manufacturer had identified variations in the rinsing process of the affected lenses. These lenses may present higher than expected levels of decanoic acid, which can cause stinging or pain when the lens is put into the eye.

The manufacturer issued a Field Safety Notice informing eye care professionals that they should return any unused product.

• Do not supply 1-Day Acuvue TruEye contact lenses as identified in the manufacturer’s Field Safety Notice.
• Return all unused product to Johnson & Johnson Vision Care.
• Consider contacting end users who have received affected product, requesting that they return unused product to their eye care professional.
• Report any adverse incidents to the manufacturer and the MHRA.

This MDA has been distributed to:

• NHS trusts in England (chief executives)
• HSC trusts in Northern Ireland (chief executives)
• NHS boards in Scotland (chief executives)
• NHS boards and trusts in Wales (chief executives)
• Primary care trusts in England (chief executives)

Onward distribution
Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• A&E departments
• Ophthalmic nurses
• Ophthalmologists
• Ophthalmology departments
• Ophthalmology, directors of
• Optometrists

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

• Community optometrists
• Directors of public health
• Dispensing opticians

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

• Private medical practitioners

Please note: CQC and OFSTED do not distribute these alerts. Sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Johnson & Johnson Vision Care Ltd
Pinewood Campus
Nine Mile Ride
Wokingham
RG40 3EW

Tel: 0800 328 9541
Fax: 01932 733 544

Email: trueyesupport@its.jnj.com 

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk