Press release: Risk of eye infection with contact lens solution

Press release

Date:	26 August 2010
Time:	11:30
Contact:	Press Office 020 3080 7651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) is warning people that a manufacturer, Abbott Medical Optics (AMO), is recalling two lots of AMO Complete multi-purpose contact lens solution because of the potential to cause eye infections.

AMO Complete multi-purpose contact lens solution may have poor fitting caps on the bottles and so the solution may not be sterile.

Two specific lots are being recalled. The details are below:
 

Complete® multi-purpose solution – affected lots in the UK
Product code	Bottle size	Lot number	Expiration date
93505	360 ml	AH01072	April 2012
93515	240 ml	AH01225	April 2012

The public should check if they have the affected product and if so return them to the original place of purchase or the manufacturer.

Abbott Medical Optics supplies its products to opticians, pharmacies and supermarkets.

Clive Bray, Director of Device Technology and Safety at the MHRA said, “We are asking people to check their contact lens solution as soon as possible because of the risk of potential eye infections.

“People can report any safety-related issues concerning medical devices to the MHRA by calling our Adverse Incident Hotline on 0207 084 3080 or via the MHRA website.”

The MHRA has also issued a Medical Device Alert (MDA) to ophthalmologists, pharmacists, opticians and optometrists who supply contact lens solutions and/or manage people who wear contact lenses. It asks them not to supply or use affected products and to return them to the manufacturer.

Notes to Editor

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

1. In general, a medical device cannot be marketed in the UK without carrying a CE Mark of Conformity. A CE mark is applied by the manufacturer to denote that the device meets the relevant regulatory requirements and performs as intended. For all but the very lowest risk devices, such as unmedicated bandages, an EC Certificate of Conformity must be obtained from an independent certification organisation, called a Notified Body, before the CE marking can be affixed. The MHRA is responsible for designating UK Notified Bodies and regularly audits them to ensure that they continue to perform to the required standards.

2. Adverse incidents relating to medical devices can be reported via the MHRA website. Information and printed incident report forms are available from: the MHRA Adverse Incident Centre on 020 7084 3080 or email: aic@mhra.gsi.gov.uk

3. To report a counterfeit device or medicine contact the MHRA dedicated 24-hour hotline on 020 7084 2701, or email counterfeit@mhra.gsi.gov.uk, or write to: Counterfeits, The Intelligence Unit, MHRA, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ.

4. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.