FOI release

Freedom of Information request on data on eye injury caused by ophthalmic dropper bottles (FOI 21-430)

Published 28 June 2021

5th May 2021 FOI 21/430 Dear

Thank you for your information request dated 14th April 2021, where you requested data (statistics) on eye injury caused by ophthalmic dropper bottles.

Some ophthalmic dropper bottles containing eye drops are regulated as a medicine and others as a medical device, determined by the way in which the drops act on the eye. As the regulations for medicines and medical devices are different, MHRA has separate databases for medicines and for medical devices, and therefore searches for the information requested need to be carried out separately on the two databases.

Medical Devices: MHRA’s medical devices adverse incident database was searched over the past 5 years (i.e. March 2016 to March 2021), and three incidents were found.

Data extracted on 29/04/2021

The data must be read together with the following explanations:       • These numbers are accurate at the time they are extracted from our database and minor changes in the numbers can occur if the reporter gives us more details later. • As MHRA do not routinely differentiate between reports of injuries due to the bottle and those due to the contents, this search was carried out using a number of keywords (including variants, such as mis-spellings of these words): “dropper” or “bottle” or “nozzle” or “container” • A report does not necessarily represent an individual incident – people may report an incident at any time after the event and people can make multiple reports. Where possible, multiple reports for the same event are linked, however as reporters are not required to complete all fields, every duplicate cannot always be linked.

Medicines: Due to the nature of how data is structured and stored in the Yellow Card database for medicines, and in order for us to provide a response to your request please can you inform us of a list of products you wish us to search our database for.

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

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU t of Medicines Division