Two French patients suffer from irreversible eye damage after surgery in which the German product Ala Octa was used.
Two French people lost the use of one eye in July 2015 after surgery using the ophthalmic product Ala Octa manufactured by the German company Alamedics Gmbh, the National Medicines Safety Agency (ANSM) told Monday. AFP.
This announcement follows the quarantine of cases reported in Spain by the Spanish Medicines Agency. She reports, in a press release published on Friday, that 41 people were affected by this product after surgery. Of these, 13 patients suffer from amaurosis causing loss of sight in the eye, 28 have retinal necrosis, optic nerve atrophy, inflammation or decreased visual acuity.
The two French cases are therefore added to this list which could be further extended. Indeed, according to the ANSM, 75 Ala Octa devices have been marketed in France since it was put on the market in 2012.
Withdrawn from the market in July
As the Spanish Medicines Agency points out, the Ministry of Health withdrew Ala Octa from the market last June. In France, the ANSM indicated its withdrawal on September 23 on its website but underlines that the decision was taken at the end of July after receiving the alert mail of German society.
In this letter, Dr Christian Lingenfelde, manager of Alamedics Gmbh, explained that “the product Ala Octa was suspected of being at the origin of degenerative processes of the retina”, and that 3 lots were to be withdrawn from sale. . Tests carried out on these batches have not yet given anything. That is why sales are halted until the circumstances are clarified.
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