Retina. 2017 Jun;37(6):1140-1151. doi: 10.1097/IAE.0000000000001680.


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.

MeSH terms

  • Acute Disease
  • Animals
  • Cells, Cultured
  • Disease Models, Animal
  • Endotamponade / adverse effects*
  • Fluorocarbons / chemistry
  • Fluorocarbons / toxicity*
  • Gas Chromatography-Mass Spectrometry / methods
  • Humans
  • Magnetic Resonance Spectroscopy / methods
  • Mass Spectrometry / methods
  • Retinal Detachment / metabolism
  • Retinal Detachment / pathology
  • Retinal Detachment / surgery*
  • Retinal Pigment Epithelium / drug effects*
  • Retinal Pigment Epithelium / metabolism
  • Retinal Pigment Epithelium / pathology
  • Retrospective Studies
  • Spectroscopy, Fourier Transform Infrared / methods
  • Swine
  • Toxicity Tests, Acute / methods
  • Visual Acuity
  • Vitreoretinal Surgery / adverse effects*
  • Vitreoretinal Surgery / methods


  • Fluorocarbons
  • perfluorooctane