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ACUTE RETINAL DAMAGE AFTER USING A TOXIC PERFLUORO-OCTANE FOR VITREO-RETINAL SURGERY
J Carlos Pastor1, Rosa M Coco, Ivan Fernandez-Bueno
1*Institute of Applied Ophthalmobiology (IOBA), Eye Institute, University of Valladolid, Valladolid, Spain; †University Clinic Hospital of Valladolid, Valladolid, Spain; ‡Thematic Cooperative Health Network for Research in Ophthalmology (Oftared), Carlos III Health Institute, Madrid, Spain; §Crystallography and Mineralogy Department, University of Valladolid, Valladolid, Spain; ¶Cell Biology Department, University of Valladolid, Valladolid, Spain; **Toxicology Department, University of Valladolid, Valladolid, Spain; ††Vision I+D, Valladolid, Spain; ‡‡Miguel Servet Hospital, Zaragoza, Spain; §§Donostia Hospital, San Sebastian, Spain; ¶¶Canaries University Hospital, Canarias, Spain; ***Castille-La Mancha University, Albacete, Spain; and †††Regenerative Medicine Network and Cell Therapy Center, Valladolid, Spain.
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.
