Principles, Application, CE-Conformity

OKULIX is a program for the calculation of the optical properties of the human eye. The designated use in the sense of the CE-rules is the power selection of intraocular lenses (IOL) and the calculation of ablation profiles for the refractive laser surgery.¹
Users of OKULIX are ophthalmologists. Other applications are not conform with the product designation. OKULIX complies with the requirements for European medical products 93/42/EWG and is labelled with the CE sign for a class I medical product under the registration code DE/CA08/3.155-01.

In a letter dated 16/09/2003 the German "Bundesamt für Arzneimittel und Medizinprodukte"; has pointed out that OKULIX has to be classified according to class IIb of European medical products, i.e. the class for excimer laser devices, if OKULIX shot files can be exported into laser devices. As long as this certification has not been performed yet, the the export of OKULIX shot files is disabled for legal reasons. Therefore, shot files can currently only be simulated in the computer, but not exported.