The National Court Prosecutor's Office has filed a complaint against the German companies Alamedics GmbH and BSI Group Deutschland and W.M. Bloss S.A, is based in Barcelona, for the manufacture, evaluation and marketing of the drug Ala Octa, which caused at least 125 cases of serious vision problems. This eye drop, based on perfluoroctane, was used as an intraoperative adjuvant in ophthalmic surgery, such as cases of retinal detachment, and was used in 28 health centers in 13 communities, the Public Ministry has reported.
Ala Octa, manufactured by Alamedics GmbH and marketed by BSI Group, caused effects such as amaurosis (situation of non-perception of light in the operated eye), atrophy of the optic nerve (optic atrophy), retinal necrosis and retinal vascular occlusion phenomena with possible sheathing of the wall of retinal blood vessels, both arterial and venous, in at least 125 reported cases.
"They were used in a very routine intervention, retinal detachment. There are many cases of people who went blind, most of them older people," Carmen Flores, the president of the El Defensor del Paciente association, an entity that denounced, explained to RAC1 " the situation of helplessness and lack of protection" of patients to the National Court.
The facts reported are, in the opinion of the Prosecutor's Office, constitutive of crimes against public health due to the manufacture, import, supply, intermediation, marketing, offering or placing on the market of the medical product.
Thus, it has reached this conclusion after having investigated the matter since last October, when it opened pre-procedural proceedings on health liability in defense of consumers and users to whom "on the occasion of retina surgery, the product Ala Octa (Perfluoroctane) was supplied. , causing adverse effects of vision loss.
In June 2015, the Spanish Agency for Medicines and Health Products (AEMPS) issued a health alert and ordered the withdrawal of the eye drops after verifying that it caused adverse effects. "The main responsibility is the manufacturer, but the AEMPS also has it. That is what it is for, to control and take immediate measures," Flores stressed. "Maybe the government should have told them to be stricter."
During this investigation, which began before the contentious-administrative and which is now filed to file a complaint, it has appreciated the existence of deficiencies in the manufacturing and deficiencies in the safety controls of the raw materials and the manufactured batches, which is why it has chosen for complaining
