First Author: M.Serrano García SPAIN
Co Author(s): M. Sanchez Garcia V. Lozano Lopez A. Psareja Rios C. Luis C. Mantolan Sarmiento
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To perform a descriptive comparative study of the results of surgical processes (retinal detachment and refloating luxated lenticulo-sacular complexes) using some type of perfluorocarbon liquid (PFCL): ALA OCT-A (Alamedics) and Perfluoron (Alcon).
Hospital Universitario de Canarias, Tenerife, Spain.
In surgical processes involving PFCL between January 2014 and December 2015, we performed a comparative analysis of preoperative, perioperative and discharge data (>1 year obtained with the Ciruret program) using IBM SPSS version 18).
Of the 46 cases where batches 150414 and 200144 of ALA OCT-A PFCL were used in surgery, 34 suffered severe ocular toxicity. Another 8 patients had adverse outcomes; it was considered that their unfavorable final result could have been conditioned by their poor initial prognosis and, therefore, were not included as cases of ocular toxicity by the manufacturer. ALA OCT-A PFCL was also used in another 4 patients who did not show any adverse effects. In the group of patients (n=153) treated with Perfluoron PFCL, none had severe adverse outcomes. Since all surgeries were performed by the same surgeons, with similar techniques, we consider that the differentiating factor was the PFCL from ALA OCT-A. The adverse outcomes detected had a common factor: severe visual impairment with optic atrophy (legal blindness) and three associated clinical pictures: 1 retinal detachment relapse, 2 vaso-occlusive phenomena and 3 retinal thinning and fibrosis.
The ALA OCT-A PFCL (Alamedics), induced severe ocular toxicity (n=34), which contrasts with the good results obtained with Perfluoron PFCL (Alcon). Ophthalmologists lack the means to distinguish which PFCL or other surgical product is potentially toxic. Up until this serious incident, our safety indicator was the CEE mark. At present, its value has been questioned. It is necessary, at the level of European health authorities, to adopt strict safety and reliability measures for surgical products, so that serious incidents such as those in 2014 and 2015 never recur.