Journal Article
Acute retinal damage after using a toxic perfluoro-octane for vitreo-retinal surgery
Pastor, JC; Coco, RM; Fernandez-Bueno, I; Alonso-Alonso, ML; Medina, J; Sanz-Arranz, A; Rull, F; Gayoso, MJ; Dueñas, A; Garcia-Gutierrez, MT; Gonzalez-Buendia, L; Delgado-Tirado, S; Abecia, E; Ruiz-Miguel, M; Serrano, MA; Ruiz-Moreno, JM; Srivastava, GK
Retina
ISSN: 0275-004X
EISSN: 1539-2864
PURPOSE: To describe a series of retinal acute toxicity cases with severe visual loss after intraocular use of a toxic perfluoro-octane (PFO). The clinical presentation is described, and the likely causes are analyzed. New biological methods for testing safety of intraocular medical devices are proposed.
METHODS: Information regarding a series of eyes suffering acute severe events after intraocular use of a toxic PFO was analyzed. Four types of spectroscopy, nuclear magnetic resonance, and chromatography were used to identify the potential PFO contaminants. Cultures of human retinal pigment epithelial cells (ARPE-19) and porcine neuroretina were used to quantify the toxicity of the suspect PFO lots.
RESULTS: Of 117 cases of intraocular toxicity, 96 were considered clearly related to the use of PFO. Fifty-three cases had no light perception, and 97 had no measurable visual acuity. Retinal necrosis (n = 38) and vascular occlusion (n = 33) were the most characteristic findings. Two hydroxyl compounds, perfluorooctanoic acid and dodecafluoro-1-heptanol, and benzene derivatives were identified as the suspected toxic agents. While existing toxicity testing failed, we proposed new tests that demonstrated clear toxicity.
CONCLUSION: Protocols to determine cytotoxicity of intraocular medical devices should be revised to assure safety. Acute toxic events should be reported to health authorities and scientific media.
Fluorocarbons; perfluorooctane; 6P60ZBK0QL; Index Medicus; Acute Disease; Gas Chromatography-Mass Spectrometry -- methods; Cells, Cultured; Spectroscopy, Fourier Transform Infrared -- methods; Toxicity Tests, Acute -- methods; Visual Acuity; Magnetic Resonance Spectroscopy -- methods; Animals; Mass Spectrometry -- methods; Retrospective Studies; Disease Models, Animal; Retinal Pigment Epithelium -- metabolism; Retinal Pigment Epithelium -- pathology; Fluorocarbons -- toxicity; Retinal Detachment -- surgery; Retinal Detachment -- pathology; Vitreoretinal Surgery -- adverse effects; Retinal Pigment Epithelium -- drug effects; Endotamponade -- adverse effects; Fluorocarbons -- chemistry; Vitreoretinal Surgery -- methods; Retinal Detachment -- metabolism
