Medical Device Alert: Intraocular lens (IOL) - hydrophilic acrylic (MDA/2010/008)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/008 or 2009/010/005/081/020.

Technical aspects
Ian Smith or Michelle Kelly
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3306 or 3145
Fax: 020 7084 3106

Email: ian.smith@mhra.gsi.gov.uk or michelle.kelly@mhra.gsi.gov.uk

Clinical aspects
Dr Christopher Brittain
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3126
Fax: 020 7084 3111

Email: christopher.brittain@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).

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

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

Northern Ireland Adverse Incident Centre (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

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).

Enquiries and adverse incident reports in Scotland should be addressed to:

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

Opacification of IOLs may occur following intracameral use of alteplase (recombinant tissue plasminogen activator, r-tPA).

The MHRA has been notified of five reports of the opacification of hydrophilic acrylic IOLs from one UK hospital. Opacification was noted between five months and seven years after alteplase treatment.

A study carried out by the hospital concluded that IOL opacification may be caused by intracameral use of alteplase to treat fibrinous membranes after cataract surgery.

Alteplase is a drug indicated for use in acute stroke, myocardial infarction, and pulmonary embolism. It is not licensed for intracameral use.

This could potentially be a problem with all hydrophilic acrylic IOLs. No manufacturing fault was found with the IOLs in this study.

Details of the study were presented as a poster at UKISCRS, 2009 (United Kingdom and Ireland Society of Cataract and Refractive Surgeons). The poster is attached in the appendix to this alert.

• Ensure that all relevant staff are made aware of this issue.
• Report all IOL opacification incidents to the MHRA.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

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

• Ophthalmic nurses
• Ophthalmologists
• Ophthalmic pharmacies
• Ophthalmology departments
• Eye units
• Ophthalmology, directors of

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• Hospitals in the independent sector
• Independent treatment centres