In the last few years, there have been hundreds of cases of blindness due to the use of some liquid perfluorocarbons.
There have been various responses from PFCL manufacturers:
- some dealt with the issue as private national affairs;
- others tried to explain what had happened through chemical parameters such as purity;
- others tried to understand what occurs to the ocular cells when they come in contact with a PFCL through biological cytotoxicity tests.
But are we looking deep enough?
According to the study Intraocular toxicity caused by MEROCTANE perfluorocarbon liquid, conducted by a group of scholars from the Instituto Universitario de Oftalmobiología Aplicada (IOBA) – Valladolid – Spain, the question is more complex than that.
Although the release of a product on the market contemplates a series of standardized procedures in compliance with ISO standards, for MEROCTANE (Meran), ALA OCTA (Alamedics) and BIO OCTANE PLUS (Biotech Opthalmology PVT) this was not enough to avoid vision loss to hundreds of people.
During clinical data analysis, the research group asks PFCL producers not only to provide them with impurity-free perfluorocarbons but also to offer guarantees with regard to the biological toxicity of each batch through direct contact cytotoxicity tests in accordance with the international standard ISO 10993-5, capable of detecting the mortality of cells in contact with the product before its intraocular use.
As manufacturer of perfluorocarbons for vitreoretinal surgery, we feel it is our duty to provide our users, who choose us every day in their operating rooms, with clear answers about the safety of our products. This is why we carry chemical and cytotoxicity tests on each lot and report the results on the traceability labels, which are contained inside each product box.