FOI release

Freedom of Information request on the dates the MHRA was notified about a clinical investigations for an Accommodative Intraocular Lens and Segmented Bifocal Intraocular Lens (FOI 21/1249 )

Published 26 May 2022

© Crown copyright 2022

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-29-november-2021/freedom-of-information-request-on-the-dates-the-mhra-was-notified-about-a-clinical-investigations-for-an-accommodative-intraocular-lens-and-segmented

FOI 21/1249

29th November 2021

Dear,

Thank you for your information request, dated 22 November 2021, where you asked for information on intraocular lenses.

I am pleased to provide you with some of the information requested, see below.

You requested:

  1. The date or dates the MHRA was notified about a clinical investigation, study or trial (or clinical investigations studies or trials) for an ACCOMMODATIVE INTRAOCULAR LENS medical device.

  2. The date or dates the MHRA was notified about a clinical investigation, study or trial (or clinical investigations studies or trials) for a SEGMENTED BIFOCAL INTRAOCULAR LENS medical device.

To date MHRA have received 7 clinical investigations involving intraocular lenses. In 2 of these notifications the devices were identified as being accommodating intraocular lenses. These were notified to MHRA on 16/12/2004 and 11/05/2006.

You requested:

  1. The number of different accommodative intraocular lenses licensed for use in the UK

  2. The names of accommodative intraocular lenses that are licensed for use in the UK.

  3. The number of different segmented bifocal intraocular lenses licensed for use in the UK

  4. The names of segmented bifocal intraocular lenses that are licensed for use in the UK.

Section 21 – Information accessible by other means: the information you have requested is already in the public domain, and can be found at https://aic.mhra.gov.uk/era/pdr.nsf/name?openpage&start=1&count=200. Since 1 May 2021 all implantable medical device placed on the UK market must be registered with the MHRA.

The Act’s section 21 exemption states that there is no right of access to information via FOI if it is reasonably available to the applicant by another route.

Unfortunately, some of the information is exempt from release under section 44:

You requested:

  1. The date of any notifications about clinical investigations, studies or trials of accommodative intraocular lenses made by Optical Express or Mr David Teenan or mr Derrick Hannan or any other employee or Director of Optical Express to the MHRA.

  2. The date of any notifications about clinical investigations, studies or trials of segmented bifocal intraocular lenses made by Optical Express or Mr David Teenan or mr Derrick Hannan or any other employee or Director of Optical Express to the MHRA.

Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.

The MHRA is satisfied that the information you have requested:

  • constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.

•            relates to the affairs of Optical Express, a business which continues to exist.

On that basis we are satisfied that section 44 of FOI Act applies and the information is exempt from release. 

The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email.

Yours sincerely

Devices division

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