In Spain, 13 patients lost at least one eye following surgery. ophthalmic surgery and 28 others were affected, according to the Spanish Agency for Medicines and Health Products (Aemps). At issue: an ophthalmic product used during eye surgery, Ala Octa, manufactured in Germany by Alamedics laboratories.
A product banned since June 2015
On September 23, 2015, the French National Agency for the Safety of Medicines and Health Products (ANSM) had announced the withdrawal of this product in the territory. It was indeed suspected of causing serious postoperative complications, including cases of amaurosis (total loss of sight). The announcement of the Aemps of the 41 patients affected by this product confirms its dangerousness. In Spain, the product has been banned since June 26, 2015 but the daily El Pais denounces the time elapsed between the first cases observed and the reactions of the doctors and the laboratory. Indeed, the first cases of total loss of sight occurred at the beginning of June and about twenty similar cases were identified before the ban was pronounced.
Determine the causes of complications
According to El Pais, the establishments concerned are eleven in number and are mainly located in the Spanish Basque country. Complications related to this product are retinal necrosis, optic nerve atrophies, visual acuity decreasesand inflammation of the ocular blood vessels. Aemps said that Spanish research institutes specializing in ophthalmology are currently carrying out chemical and toxicological analyzes to determine the origin of the complications. In France, no case linked to the product Ala Octa has been reported.
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