Abstract
Purpose
To compare the analytical quality characteristics of currently available CE-marked perfluorocarbon liquids (PFCL) applied intraoperatively during vitreoretinal surgery.
Methods
Twenty-one samples of 8 brands of perfluorooctane (PFO) and 25 samples of 13 brands of perfluorodecalin (PFD) were analysed. Gas chromatography coupled with mass spectroscopy (GC/MS) was used to determine the content of the main product. The amount of reactive and underfluorinated impurities was analysed and expressed as an H-value using fluoride selective potentiometry after a chemical transformation reaction to detect impurities that triggered both acute and latent toxic effects. UV-active substances were determined in order to draw conclusions on the integrity of primary packaging components. Moreover, we controlled for any 1H-PFO contamination in PFO, as it is known to modify PFO’s surface characteristics.
Results
Significant differences in the tested products’ purity profiles were detected. The PFO batches revealed H-values ranging from < 10 to 1230 ppm and 1H-PFO concentrations ranging from < 1 to 376 ppm. Leachable substances from packaging components cause UV absorption in the 0.1 to > 3 AU range. The PFD batches revealed H-values ranging from < 10 to 70 ppm and leachables from packaging components resulting in absorbances in the 0 AU to 3.2 AU range.
Conclusion
The quality characteristics of the analysed PFCL vary significantly, not only among different brands but among batches from the same manufacturer as well. Manufacturers should communicate the purity of their products in an understandable and clear manner. This would require providing a complete certificate of analysis focussing especially on quality characteristics to enable vitreoretinal surgeons to differentiate between the effects from the PFCL itself and those from impurities.
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References
Chang S et al (1988) Intraoperative perfluorocarbon liquids in the management of proliferative vitreoretinopathy. Am J Ophthalmol 106(6):668–674
Mendez-Martınez S, Calvo P, Rodriguez-Marco NA, Faus F, Abecia E, Pablo L (2018) Blindness related to presumed retinal toxicity after using perfluorocarbon liquid during vitreoretinal surgery. Retina Phila Pa 38:1856–1864
Pastor JC, Coco RM, Fernandez-Bueno I et al (2017) Acute retinal damage after using a toxic perfluorooctane for vitreo-retinal surgery. Retina Phila Pa 37:1140–1151
Pastor Jimeno JC, Coco Martin RM (2017) The acute toxicity problem with some perfluorooctanes. Arch Soc Esp Oftalmol 92(10):455–457
Coco RM, Srivastava GK, Andrés-Iglesias C, Medina J, Rull F, Fernandez-Vega-Gonzalez A, Fernandez-Bueno I, Dueñas A, Pastor JC (2019) Acute retinal toxicity associated with a mixture of perfluorooctane and perfluorohexyloctane: failure of another indirect cytotoxicity analysis. Br J Ophthalmol 103(1):49–54
Srivastava GK, Alonso-Alonso ML, Fernandez-Bueno I et al (2018) Comparison between direct contact and extract exposure methods for PFO cytotoxicity evaluation. Sci Rep 8:1425
Menz D-H, Feltgen N, Menz H, Müller B-K, Dresp J, Hoerauf H (2018) How to ward off retinal toxicity of perfluorooctane and other perfluorocarbon liquids? Invest Ophthalmol Vis Sci 59:4841–4846. https://doi.org/10.1167/iovs.18-24698
Menz D-H, Feltgen N, Lechner T, Menz H, Müller B-K, Dresp J, Hoerauf H (2019) Hydrofluoric acid and other impurities in toxic perfluorooctane batches. Trans Vis Sci Tech 8(3):24. https://doi.org/10.1167/tvst.8.3.24
Menz H, Feltgen N, Lechner T, Menz D-H, Müller B-K, Dresp J, Hoerauf H (2019) Tracing the cause of toxic batches of perfluorooctane. Poster Euretina, Paris
Dresp J Benchmarking different brands of silicone oils. Graefes Arch Clin Exp Ophthalmol. Submitted for publication
Ruzza P, Gatto C, Ragazzi E, Romano M, Honisch C, Tóthová J (2019) H-content is not predictive of perfluorocarbon ocular endotamponade cytotoxicity in vitro. ACS Omega 2019(4):13481–13487
Sparrow JR, Ortiz R, MacLeish PR, Chang S (1990) Fibroblast behavior at aqueous interfaces with perfluorocarbon, silicone, and fluorosilicone liquids. Invest Ophthalmol Vis Sci 31(4):638–646
Acknowledgements
I would like to thank the analytical department of Pharmpur GmbH for their GMP-compliant performance of the PFCL analyses.
Identification code
- Code:
-
Brand
- B:
-
Alchimia
- C:
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Arcadophta
- D:
-
Bausch&Lomb
- E:
-
Biotech
- F:
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DORC
- G:
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FCI
- H:
-
Fluoron
- J:
-
Howard Instruments
- K:
-
Meran Medikal
- L:
-
MIray Medikal
- M:
-
Oculentis
- N:
-
Teknomek
- O:
-
Pharmpur
- P:
-
Alcon
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No funding was received for this research
Conflict of interest
Author is Chairman of Working Committee NA 027-01-20 of German Institute for Standardization (DIN) and Leader of project ISO 16672, Ophthalmic implants—Ocular endotamponades in the International Standardization Organization (ISO).
In the past, the author has been consulting for a variety of ophthalmic companies (Bausch and Lomb, Chauvin, Cromapharma, DORC, HumanOptics, Hyaltech, i.com medical, MIRO, Pharmpur, Second Sight, THEA, Technolas Perfect Vision, Valeant) in regulatory affairs, quality management, research and development.
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Dresp, J.H. Benchmarking different brands of perfluorocarbon liquids. Graefes Arch Clin Exp Ophthalmol 259, 21–27 (2021). https://doi.org/10.1007/s00417-020-04964-6
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DOI: https://doi.org/10.1007/s00417-020-04964-6