Medical Device Alert: AMO Complete® multi-purpose contact lens solution (MDA/2010/067)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/0067 or 2010/007/023/081/008.

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

Tel: 020 7084 3306/3145
Fax: 020 7084 3145

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

Clinical aspects
Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3126
Fax: 020 7084 3111

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).

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

Recall of specific product lot numbers.

Sterility of the product may be compromised due to poor fitting caps.

The manufacturer, Abbott Medical Optics Inc (AMO), has identified that due to a manufacturing error certain lots of product may have poor fitting caps, which could compromise the sterility of the product.

Product that is non-sterile could have the potential to cause eye infections.

The manufacturer has issued a Field Safety Notice recalling affected product.

• Do not supply or use affected lots of AMO Complete multi-purpose contact lens solution as identified in the manufacturer’s Field Safety Notice.
• Return all affected product to the manufacturer.
• Report adverse incidents to the manufacturer and the MHRA.

This MDA has been distributed to:

• NHS trusts in England (chief executives)
• Health Protection Agency (HPA) (directors)
• 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 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:

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

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

• Private medical practitioners

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

• Community optometrists
• Community pharmacists
• Directors of public health
• Dispensing opticians

Michael Faust
Quality and Compliance Manager
AMO Germany GmbH
Rudolf-Plank-Str 31 76275
Ettlingen
Germany

Tel: +49 7243 729 474
Fax: +49 7243 58971 474

Email: michael.faust@amo.abbott.com