The Prosecutor’s Office asks to investigate the marketing of a medical product that caused loss of vision

2024-01-31 10:23:14

Updated Wednesday, January 31, 2024 – 11:23

The Prosecutor’s Office has asked the National Court to investigate several German companies for the manufacture and marketing of the Ala Octa medical productapplied in retinal operations, and which produced loss of vision and other adverse effects in the patients on whom it was applied.

The lieutenant prosecutor of the National Court, Marta Durantez, has filed a complaint in which she asks the court to collect from the health centers that reported incidents with the Ala Octa product the data of patients who suffered injuriesdeclaring them as injured parties with an offer of shares.

In addition, the prosecutor requests that, once the legal persons allegedly responsible have been determined, an organizational chart be required from them for the purposes of determining the natural persons who could be responsible. Finally, ask what to wonder in court to the corresponding investigated.

The Prosecutor understands that the events reported could be constituting crimes against public health for the manufacture, import, supply, intermediation, marketing, offering or placing on the market of the Ala Octa medical product and serious injuries.

The Public Ministry assures that “the product caused the patients to whom it was supplied adverse health effects such as amaurosis (a 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 the blood vessels of the retina, both arterial and venous. “.

“The investigation into the product noted the existence of deficiencies in manufacturing and deficiencies in raw material safety controls and the batches manufactured. It was used by the Spanish health system in 28 health centers, from 13 autonomous communities, with a total number of 125 notified cases”, ade.

The companies that would have marketed the product are, according to the Prosecutor’s Office, Alamedics GmbH & Co.KG and BSI Group Deutschland and the Barcelona-based company WM Bloss SA.