We thought France was spared. It is not so. At the time when a German ophthalmic product, Ala Octa, is suspected to be the source of the functional loss of the eye in thirteen Spanish patients, the business is rebounding in France. A French patient also reportedly lost the use of one eye after surgery. The aqueous ophthalmic solution, manufactured by the German company Alamedics Gmbh, is once again on the dock.
Monday, November 2, the National Agency for the Safety of Medicines and Health Products (ANSM) explained in a press release to have “been informed that two patients suffered a functional loss of one eye following retinal surgeries performed in early July 2015”, confirming that the product Ala Octa was used for these two procedures.
The ANSM recalls that the products on the market were recalled, as a precaution, as of July 15, 2015 and distribution was stopped. In France, 10 units have been used among the 75 marketed since 2012.
The responsibility for the ophthalmic product for one of the two French patients has already been ruled out by the surgeon. For the other patient, the investigation is ongoing. “The ANSM is currently carrying out investigations in conjunction with the competent European authorities in order to determine the exact causes of these incidents”, specifies the agency.
A bigger deal in Spain
For the moment, there is no need to worry, since we are still far from the extent of the complications observed in Spain. Thirteen patients reportedly suffered side effects after using Ala Octa during surgery. Among the serious complications associated with this product: loss of visual acuity, necrosis of the retina, atrophies of the optic nerve, or inflammation of the ocular blood vessels.
>> To read also: AMD: first transplant of a bionic eye
Eye tattoo: the new fashion that worries the United States
A Chinese woman had lice in her eye
