Acute intraocular toxicity caused by perfluorocarbon liquids: safety control systems of medical devices

Abstract

Background Acute retinal toxicity has been demonstrated to be associated with the intraoperative use of perfluorocarbon liquids (PFCLs), especially perfluorooctane (PFO). Recently, several cases of PFO-associated blindness have been reported in Spain, Holland, France, Italy, the Middle East, and South America. Methods As a result, a new ISO guideline ( ISO 16672:2020) was drafted, discussed, approved, and released in 2019. This recent ISO16672:2020 guideline recommends performing direct cytotoxicity tests as an option along with chemical analysis to measure PFCL quality (purity and safety). Results In this review paper, it has been emphasized why an appropriate biological test, specifically direct exposure of PFCL to live cells, for measuring cytotoxicity must be performed with each PFCL batch along with chemical analysis. Conclusions The paper intends to compile all available information to discuss possible approaches for avoiding adverse clinical cases in future.

Vitreous Substitutes from Bench to the Operating Room in a Translational Approach: Review and Future Endeavors in Vitreoretinal Surgery

“…One of the main disadvantages of PFCLs is that they are approved only for intra-operative use only, since many animal studies have indicated that leaving PFCL in the vitreous cavity as a post-operative tamponade agent causes retinal toxicity [ 144 , 145 , 146 ]. It is not completely clear where PFCL’s toxicity stems from, but it has been shown that it could be a combination of induced inflammation, impurities and chemical toxicity and mechanical trauma, not only in the long term but also acutely [ 147 , 148 , 149 , 150 ]. Some of these impurities have been identified as molecules with nitrogen bonds, as well as compounds containing hydrogen and fluoride [ 151 , 152 ].…”

Exogen bedingte Retinopathien

“…Eine Abgrenzung zu anderen Ursachen ist wesentlich, um den Einsatz gleicher Chargen bei anderen Patienten möglichst zu vermeiden. Eine toxikologische Untersuchung einer verdächtigen Charge sollte erfolgen 39 , 40 . Es besteht auch eine Variabilität bei Silikon für intraokulare Tamponaden, je nach Zusammensetzung beeinflusst dies potenziell zytotoxische Wirkungen 41 , 42 .…”