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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.
Acute intraocular use of toxic perfluoro-octane (PFO) caused severe vision loss in 96 cases. New safety testing methods are proposed to prevent future toxicity events from medical devices.
Area of Science:
- Ophthalmology
- Toxicology
- Biomedical Engineering
Background:
- Intraocular use of perfluoro-octane (PFO) has been associated with severe visual impairment.
- Understanding the specific toxic agents and mechanisms is crucial for patient safety.
Purpose of the Study:
- To detail acute retinal toxicity cases resulting from intraocular PFO.
- To identify the causative agents and analyze the clinical presentation.
- To propose novel biological methods for assessing intraocular medical device safety.
Main Methods:
- Analysis of clinical data from 117 eyes with intraocular toxicity.
- Spectroscopy, nuclear magnetic resonance, and chromatography to identify PFO contaminants.
- In vitro toxicity testing using human retinal pigment epithelial cells (ARPE-19) and porcine neuroretina.
Main Results:
- Ninety-six of 117 cases were linked to toxic PFO use, with significant vision loss (53 no light perception, 97 no measurable visual acuity).
- Characteristic findings included retinal necrosis (38 cases) and vascular occlusion (33 cases).
- Identified toxic agents included hydroxyl compounds (perfluorooctanoic acid, dodecafluoro-1-heptanol) and benzene derivatives; proposed tests showed clear toxicity where existing methods failed.
Conclusions:
- Current cytotoxicity testing protocols for intraocular medical devices require revision to ensure patient safety.
- Mandatory reporting of acute toxic events to health authorities and scientific media is essential.

