PFCL SIRINGA

The device in question is fluorinated octadecafluorodecaidronaphthalene (cis+trans), also known as perfluorodecalin (PFD).

The PFD underwent biocompatibility testing before packaging.

PFCL (Perfluorodecaline) is a high-purity, high-transparency, high-density liquid used for temporary tamponade of the vitreous chamber during eye surgery, with a maximum residence time inside the eye of one hour. The PFCL (perfluorocarbon for eye surgery) medical device belongs to Class IIA medical devices.

PFCL belongs to a line of products approved for marketing since 1998 (by Notified Body 0373, EC Certificate 081QPT011) and registered in the Italian Ministry of Health database since 2008.

The PFCL is inserted into the vitreous cavity after carefully removing the central vitreous and, if necessary, the peripheral vitreous. Before infusion, it is necessary to make sure that there is no free vitreous that can mix with PFCL.

PFCL should be removed from the eye within a maximum of one hour after contact.

Perfluorocarbons are colorless, nontoxic, chemically and physiologically inert compounds that are widely used in vitreoretinal surgery for retinal distension. The surface and contact tension are such that there is no risk of passage of these compounds under the retina in giant ruptures. Due to their high density, which in the case of PFCL (Perfluorodecalin) has a typical value of 1.941 g/ml, perfluorocarbons are also considered excellent products for distending and re-adhering detached retina.

Perfluorocarbons cannot be used long-term; they are only allowed to be used intraoperatively and must be removed at the end of the surgical procedure because their stay in the eye induces retinal changes within a relatively short time.