A paper impregnated with fluorescein strips has been given the permission by the Optical Confederation to be used in clinical investigations in primary care until further notice after it was stated there were no major risks involved with its use.
Practitioners who utilize controlled amounts of fluorescein, vital for the assesment of the anterior eye surface,tonometry and some contact lens fittings will welcome the decision.
The decision comes after a withdrawal from the global market of Bausch+Lomb Fluorets. It was not a safety issue that prompted the withdrawal. Two months later, the Confederation issued advice to use 1 per cent fluorescein minims while the problem was resolved, however it was then announced that stocks of the 1 per cent fluorescein minims were expleted, with no more to be produced until this autumn.
Though the CE marked fluorescein impregnated strips were available, the UK MHRA had classified the Bausch+Lomb Fluorets as a medicinal product meaning that after it's withdrawal there there were no other licensed fluorescein strips available to professionals.
The MHRA, recognised the possible consequences of their withdrawal and did not take enforcement action against suppliers of CE marked medical device fluorescein strips to the UK market until the EU position was clarified, therefore permitting their sale in the UK.
The Optical Confederation panel have said that failure to use fluorescein when clinically indicated in a primary care setting due to non-availability of a suitable pharmaceutical preparation would put patients at risk through a failure or delay to recognise sight threatening ocular conditions.