J. Carlos Pastor
University of Valladolid, Valladolid, Spain
Abstract
IOBA has been working on medical devices for use in intraocular surgery since 1991, mainly silicone oil. In 2013, 4 cases of acute blindness were reported after surgery with a Turkish-made perfluoro-octane (PFO). There were also cases in Chile and the product was withdrawn but not analyzed. Between 2014 and 2015 there were reported 117 cases of acute blindness in Spain with a German-made PFO. Officially there were no other cases reported in Europe and since the product had been tested according to ISO standards, the manufacturer attributed the blindness to misuse by Spanish ophthalmologists. Dr. Srivastava discovered that the test used had been inadequate and the IOBA chemists detected the presence of blinding contaminants.dodecafluoroheptanol; P-Xylene; (3) Ethyl-benzene; 1,4-Dimetyl-benzene; and Perfluorooctanoic acid (PFOA). In 2016, another 4 cases of blindness were reported with a product manufactured in India, a mixture of perfluorooctane and perfluorohexyloctane, of which there are no published references in the literature supporting its benefits, containing concentrations of bromotributylstannane ten times higher than those considered toxic. Finally in 2019 we accessed batches of the first Turkish product, checking the presence of Perfluorododecanoic acid, Pentadecafluoro octanoic acid and 1H,1H-Perfluoro-1-heptanol. We were appointed members of the ISO Standards Committee and we managed to change the one that refers to these products. Subsequently, since May 2021 it is mandatory that all medical devices that want to obtain the CE marking comply with the MDR (Medical Device Regulation) regulations that establish a centralized control body (Eudamed), where all adverse effects must be reported, standardize the laws of all the countries of the EU. It demands specific information on the risks and benefits of each product, which must also be reported periodically. And other measures that tighten security conditions to avoid similar problems in the future. And the obligation of more extensive clinical information.
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