Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. Medical Device Alerts (MDAs) are the MHRA's prime means of communicating safety information to medical device users in health and social care. Each MDA is designated either for Immediate action or Action. MDAs may also be used to provide updated information.
Below are the MDAs we have published that are of particular relevance to opthalmologists. To see a complete list of our MDAs, please visit the Medical Device Alert section of our website.
Recent Medical Device Alerts relating to ophthalmology
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21 Jun 2011 | Medical Device Alert: Ophthalmic surgical instrument manufactured by Keeler Ltd (MDA/2011/071)
This Medical Device Alert has been withdrawn and superseded by MDA/2011/081.
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07 Jun 2011 | Medical Device Alert: Alcohol skin preparation pads, swabs and swabsticks manufactured by Triad Group Inc since 2007 (MDA/2011/065)
This Medical Device Alert has been issued because the manufacturers published Field Safety Notices (FSN) for these devices in April 2011, but have not had sufficient confirmation from users that they have received and acted on this information.
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17 May 2011 | Medical Device Alert: Powder free examination gloves manufactured by BM Polyco Ltd (MDA/2011/049)
This Medical Device Alert has been issued as gloves from the affected lots may have pinholes, which could increase the risk of cross infection and leakage.
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11 May 2011 | Medical Device Alert: Biogel Eclipse Reveal surgical gloves manufactured by Molnlycke Health Care (MDA/2011/043)
This Medical Device Alert has been issued as the company has received a small number of reports from customers overseas that pinholes have been found on the package seal of the Biogel Eclipse Reveal gloves. No reports have originated from the UK.
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03 Mar 2011 | Medical Device Alert: Alcohol skin preparation pads, swabs, and swabsticks manufactured by Triad Group Inc for H&W cv since 2007 (MDA/2011/023)
This Medical Device Alert has been issued because of a potential bacterial contamination of alcohol swabs which may lead to skin infection. This MDA updates MDA/2011/013R with details of additional manufacturers’ device packs and kits that contain the affected swabs.
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11 Feb 2011 | Medical Device Alert: Alco-Prep® alcohol skin preparation pads, swabs and swabsticks manufactured by H&W cv since 2007 (MDA/2011/013R)
This Medical Device Alert has been issued because this product has been recalled due to potential bacterial contamination of alcohol swabs which may lead to skin infection. Immunocompromised individuals are at greater risk of serious infection.
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04 Jan 2011 | Medical Device Alert: All medical devices (MDA/2011/001)
This Medical Device Alert has been issued due to growing levels of reporting of medical device-related adverse incidents to the MHRA’s Adverse Incident Centre in a changing health and social care environment.
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01 Dec 2010 | Medical Device Alert: 1-Day Acuvue TruEye contact lenses manufactured by Johnson & Johnson Vision Care (Ireland) (MDA/2010/093)
This Medical Device Alert has been issued because lenses from affected lots can cause stinging or pain upon insertion because of higher than expected levels of decanoic acid.
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26 Aug 2010 | Medical Device Alert: AMO Complete® multi-purpose contact lens solution (MDA/2010/067)
This Medical Device Alert has been issued as the sterility of the product may be compromised due to poor fitting caps, potentially causing eye infections.
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21 Jan 2010 | Medical Device Alert: Intraocular lens (IOL) - hydrophilic acrylic (MDA/2010/008)
This Medical Device Alert (MDA) has been issued as opacification of intraocular lens (IOLs) may occur following intracameral use of alteplase.
