After the health alert that suspended the marketing authorization of Perfluoron® (product used in vitreo-retina surgery procedures), the new IOBA-CYTOTEST, patented methodology, developed in Valladolid, confirmed that the analyzed batches of this product were safe.
The European requirements (Directive 93/42/EEC Annex IX) recommended the International Organization for Standardization (ISO) 10993 and 16672 to assure safety of intraocular devices (Class IIb). Unfortunately, IOBA research has proven that some of the existing tests that comply with such regulations are unable to detect toxicity.
The new direct methodology (IOBA-CYTOTEST) has been developed in order to support the safety of some intraocular medical devices, by IOBA (Eye Institute of the University of Valladolid), which has commissioned Vision R&D to perform it.
European Authorities and main suppliers of intraocular medical devices are now in contact with IOBA and Vision R&D to propose a modification of the current ISO norms.