Instituto Universitario de Oftalmobiología Aplicada (IOBA), Eye Institute, University of Valladolid, Paseo de Belen, 17, 47011, Valladolid, Spain.
Oftared, Carlos III National Institute of Health, Madrid, Spain.
Sci Rep. 2021 Jan 12;11(1):599. doi: 10.1038/s41598-020-79561-y.
Serious intraocular toxicity cases have been reported worldwide after the use of different perfluorocarbon liquids. The current study reports for the first-time the clinical pictures of cases of acute intraocular toxicity caused by MEROCTANE, a perfluoro-octane commercialized by a Turkish company and distributed in many countries. A series of 18 cases from Chile and Spain was retrospectively analysed. To evaluate the impurity profile, a suspicious MEROCTANE sample (lot OCT.01.2013) was analysed by gas chromatography mass spectrometry and compared with a non-suspicious sample of the same commercial perfluoro-octane (lot OCT 722011). Cytotoxicity was tested following a direct-contact method, taking into consideration the high volatility and hydrophobicity of perfluoro-octane and following the ISO 10993 guideline. Cytotoxicity test showed clear cytotoxic effects of the analysed batch (less than 9% of cell viability). Moreover, chemical analysis demonstrated the presence of many contaminants, some highly toxic (acids and alcohols). Perfluorocarbon liquids are useful tools for intraocular surgery but companies and Agencies of Medical Devices must implement measures that guarantee the safety of these products based on both chemical and cytotoxicity analysis for every batch. Medical staff should be encouraged to report any suspected case to their respective National Agencies.
在使用不同的全氟碳液体后,全球范围内都有报道严重的眼内毒性病例。本研究首次报告了由土耳其公司商业化并在许多国家销售的全氟辛烷 MEROCTANE 引起的急性眼内毒性病例的临床图片。对来自智利和西班牙的一系列 18 例病例进行了回顾性分析。为了评估杂质情况,对可疑的 MEROCTANE 样品(批号 OCT.01.2013)进行了气相色谱-质谱分析,并与同一商业化全氟辛烷(批号 OCT 722011)的非可疑样品进行了比较。根据 ISO 10993 指南,考虑到全氟辛烷的高挥发性和疏水性,采用直接接触法进行了细胞毒性测试。细胞毒性测试显示分析批次具有明显的细胞毒性作用(细胞活力小于 9%)。此外,化学分析表明存在许多污染物,其中一些具有高度毒性(酸和醇)。全氟碳液体是眼内手术的有用工具,但医疗器械公司和机构必须根据每批产品的化学和细胞毒性分析,采取措施保证这些产品的安全性。应鼓励医务人员向各自的国家机构报告任何疑似病例。