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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective analysis involving 80 patients, 7 patients aged between 47−71 years (5 men and 2 women) were described, who developed blindness related to retinal toxicity following exposure to perfluorocarbon liquid [Ala Octa] during vitreoretinal surgery [route, dosage, time to reaction onset and outcomes not stated].
Case 1: A 60-year-old man was diagnosed with superior macula-on rhegmatogenous retinal detachment on his left eye. His best corrected visual acuity (BCVA) was 20/20. Two days later, a 23G-pars plana vitrectomy with sulfur hexafluoride injection was performed. The perfluorocarbon liquid (batch number: 150414) was used along the surgery for 10 minutes. After 10 days, he developed signs of retinal toxicity such as sticking papillary traction, epiretinal fibrosis...
- Mendez-Martinez S, et al. BLINDNESS RELATED TO PRESUMED RETINAL TOXICITY AFTER USING PERFLUOROCARBON LIQUID DURING VITREORETINAL SURGERY. Retina 38: 1856-1864, No. 9, Sep 2018. Available from: URL: http://doi.org/10.1097/IAE.0000000000001783 - Spain