An ophthalmic surgery product, Ala Octa, has been found to be responsible for 41 post-operative complications, 13 of which led to the loss of one eye, according to Spanish health authorities.
On September 23, the National Medicines and Health Products Safety Agency (ANSM) announced the withdrawal in France of an ophthalmic surgery product, Ala Octa, marketed by Alamedics, a German laboratory. He was then suspected of having caused various post-operative complications, which could lead to total loss of sight.
The Spanish Medicines Agency (AEMPS) confirmed on October 30 that 41 patients suffered from lesions following the use of the product in Spain, including 13 particularly severe cases of amaurosis, i.e. a total loss of sight. an eye.
In addition to these cases, AEMPS identified other sequelae in the other 28 patients: retinal necrosis, optic nerve atrophy, reduced visual acuity, inflammation and vasculitis.
Too slow a reaction
According to El Pais, eleven establishments, in particular in the Spanish Basque country, would be concerned. The Spanish daily was surprised at the slow reaction of doctors and Alamedics, who should have been alarmed earlier and stopped using the product from the first cases identified.
“They operated on me on June 2 at the public hospital in San Sebastián and the next day I could not see anything in my left eye,” Mikkel Gonzalez told AFP. However, it was not until June 26 that the product was withdrawn from the market in Spain, after the announcement of twenty suspected cases by the manufacturer of the product.
In France, no case has yet been declared, and only one has been identified in Italy. No explanation of the cause of the complications has yet been provided. “Samples were sent to a Spanish research institute specializing in ophthalmology for chemical and toxicological analyzes,” says AEMPS.
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