Acute Retinal Damage After Using a Toxic Perfluoro-Octane for Vitreo-Retinal Surgery

Pastor, J. Carlos; Coco, Rosa M.; Fernandez-Bueno, Iván; Alonso-Alonso, María Luz; Medina, Jesús; Sanz-Arranz, Aurelio; Rull, Fernando; Gayoso, Manuel J.; Dueñas, Antonio; García-Gutiérrez, María T.; González-Buendía, Lucía; Delgado-Tirado, Santiago; Abecia, E.; Ruiz-Miguel, Miguel; Serrano, Miguel A.; Ruiz-Moreno, José M.; Srivastava, Girish K.

doi:10.1097/iae.0000000000001680

Cited by 52 publications

(126 citation statements)

References 12 publications

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“…Some cases showed acute retinal necrosis of variable extension during the first postoperative week, optic nerve atrophy 1 month after surgery and arterial and/or venous retinal vascular occlusion. These findings were associated with the use of abovementioned medical devices [17,18] (Fig. 1).…”

Section: Introductionmentioning

confidence: 78%

“…201630708 and International PCT No. ES2017/ 070365) aims at improving this shortcoming by directly exposing human retinal cell cultures (ARPE-19 cell line) and porcine neuroretina organotypic cultures to PFO liquids [17,19]. This new test method has detected toxic lots of the PFO liquids which have previously been CE certified for safety but, unfortunately, had produced severe and acute clinical complications.…”

Section: General Suggestionsmentioning

confidence: 99%

“…Therefore, ISO rules could be changed making direct tests mandatory. There are also some other critical factors that must be controlled before evaluating possible toxic effects, such as the duration of contact and maintenance of cultures [17,19]. The importance of purity of the raw material, the purification process (e.g., two-step purification for SOs) and the quality management of the storage process are additional essential aspects.…”

Section: General Suggestionsmentioning

confidence: 99%

“…1). Interestingly, the pharmaceutical companies selling these products adhered to the European guidelines for toxicity testing, but some of the safety tests failed to identify the toxic medical devices although they were performed according to the requirements of the Health Agencies and International Organization for Standardization (ISO) norms [17,19].…”

Section: Introductionmentioning

confidence: 99%

“…As mentioned earlier, there have been reports of retinal toxicity associated with the use of different batches of PFCL products that left over 130 patients blind in several European countries. The investigations by the IOBA (Eye Institute of Valladolid's University, Spain) revealed that different batches of AlaOcta (Alamedics, Germany) showed different cytotoxic effects associated not only with the presence of OH derivatives but also other contaminants not directly related to the PFCL degree of fluorinization [17,30]. These findings probably could be linked to other cases of severe vision loss in France, Switzerland, Germany and Saudi Arabia, without being officially reported.…”

Section: Introductionmentioning

confidence: 99%

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Retinal Toxicity of Medical Devices Used during Vitreoretinal Surgery: A Critical Overview

et al. 2018

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Retinal toxicity/biocompatibility of medical devices in direct contact with the retina is an important subject for clinicians and scientists. As these effects are not very frequent, there is also a relative lack of information for many clinicians. The past has taught us multiple times that there is a significant safety problem associated with severe loss of vision in affected patients. In this review, we want to classify medical products that are used in the back of the eye, describe recent examples of toxicity, critically reflect on the regulations that exist and suggest improvements that can be done to ensure patient safety without hindering innovation. Methods: Critical review of the recent papers and personal experience of the authors in this issue. Medical devices used in the back of the eye and recent examples of toxicity are described, regulations that exist are critically reflected and improvements suggested that can ensure patient safety without hindering innovation. Results: There is clear evidence of toxicity after intraocular surgery in any category. Some cytotoxic indirect methods have failed in detecting this toxicity. Some ISO rules do not seem appropriate. Postmarketing safety is missing. There is little data on this issue. Conclusions: The absence of a clear regulation of the production, purification and evaluation of the toxic effects of the medical devices supposes the possibility that products are not sufficiently safe to obtain the CE mark.

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Section: Introductionmentioning

confidence: 78%

Section: General Suggestionsmentioning

confidence: 99%

Section: General Suggestionsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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