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Intraocular toxicity caused by MEROCTANE perfluorocarbon liquid.
Rosa M Coco-Martin1,2, Cristina Andrés-Iglesias3, Girish K Srivastava1
1Instituto Universitario de Oftalmobiología Aplicada (IOBA), Eye Institute, University of Valladolid, Paseo de Belen, 17, 47011, Valladolid, Spain.
Scientific Reports
|January 13, 2021
Summary
Acute intraocular toxicity from MEROCTANE, a perfluoro-octane liquid, was identified in 18 cases. Chemical analysis revealed toxic contaminants and cytotoxicity in the surgical product.
Area of Science:
- Ophthalmology
- Toxicology
- Materials Science
Background:
- Perfluorocarbon liquids are utilized in intraocular surgery.
- Previous reports indicate serious intraocular toxicity associated with various perfluorocarbon liquids.
- MEROCTANE is a commercial perfluoro-octane used in ophthalmic procedures.
Purpose of the Study:
- To report the clinical presentation of acute intraocular toxicity cases linked to MEROCTANE.
- To analyze the chemical composition and cytotoxicity of a suspicious MEROCTANE batch.
Main Methods:
- Retrospective analysis of 18 patient cases from Chile and Spain.
- Gas chromatography-mass spectrometry analysis of MEROCTANE samples to identify impurities.
- In vitro cytotoxicity testing using a direct-contact method adhering to ISO 10993 guidelines.
Main Results:
- Clinical data from 18 patients revealed acute intraocular toxicity associated with MEROCTANE use.
- Analysis of a suspicious MEROCTANE batch (lot OCT.01.2013) detected numerous toxic contaminants, including acids and alcohols.
- Cytotoxicity tests demonstrated significant cell death (less than 9% cell viability) in the analyzed MEROCTANE batch.
Conclusions:
- MEROCTANE has been associated with severe intraocular toxicity.
- Chemical and cytotoxicity analyses are crucial for ensuring the safety of perfluorocarbon liquids used in surgery.
- Medical device manufacturers and regulatory agencies must implement stringent quality control measures for all batches.
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