The current EU and International Standards Organisation’s (ISO) approved procedures for determining the safety of medical devices used for vitreoretinal surgery may need to be re-evaluated, according to J Carlos Pastor MD, PhD, IOBA (Eye Institute), University of Valladolid, Valladolid, Spain.
“Perfluoro-octane has been used for many years, with an apparent safety. But cases of acute toxicity related to three different products have been reported in 2013, 2015 and 2016. We do not know the exact reasons, but what is important is that the final and finished product is completely safe and that is achieved by performing appropriate cytotoxicity tests,” Dr Pastor told EuroTimes in an interview.