Clinical characteristics of proven acute intraocular toxicity by perfluorocarbon liquids (PFCL) used in retinal surgery

Abstract

Purpose : Adequate collaboration among ophthalmologists, scientific societies, and the Spanish Agency of Medicines and Medical Devices (AEMPS) have allowed the identification of proven cases of acute toxicity by some PFCL used in retinal surgery since 2013. Our aim is to define the clinical patterns of such toxicity so that retinal specialists from other countries can recognize potential cases and declare them to their National Health Agencies

Methods : Clinical cases of suspected acute toxicity declared to the AEMPS were reviewed (n: 129). Since 2015 (n=125), all cases were analyzed for potential cell cytotoxicity using a direct contact method developed by our group (Srivastava GK et al. Scientific Reports 2017;1425). Those producing >30% cell mortality were considered cytotoxic (ISO guidelines 16672 and 10993). Also chemical analysis were done by Fourier-transformed infrared (FTIR) spectroscopy and gas chromatography coupled to a single quadrupole mass spectrometer (GC-MS). Clinical information of the confirmed cases was evaluated and grouped by an expert committee of the Spanish Vitreo-Retina Society (SERV).

Results : 125 of the 129 suspected cases were fully confirmed to have used cytotoxic PFCL. The following toxic compounds were identified in different lots: ethyl benzene, dodecafluoroheptanol, perfluorooctanoic acid, P-xylene, O-xylene and bromotributyl stannane. Four major clinical patterns were defined: 1. Amaurosis or no light perception the day after the surgery is highly suspicious; 2. Optic nerve atrophy usually detected in less than 1 month after surgery not related to ocular hypertension; 3. Extensive areas of acute retinal necrosis; or 4. Retinal vascular occlusion(arterial or and/venous) w/w retinal hemorrhages.

Conclusions : For reasons not yet fully clarified, certain PFCL are producing profound visual loss right after their use in retinal surgery. Although changes have been proposed to modify ISO guidelines (16672, ophthalmic implants/ocular endotamponades), clinicians must be aware of this problem so that they can immediately report suspected cases to their respective National Health Agencies. Nevertheless manufacturing companies collaboration is required to avoid these problems in the future.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.