UPDATE ON THE DISCONTINUATION OF THE MARKETING OF THE OPHTHALMIC SURGICAL PRODUCT ALA OCTA IN JULY 2015
The French National Agency for the Safety of Medicines and Health Productswas informed that two patients suffered functional loss of an eye following retinal surgeries carried out at the beginning of July 2015. The ALA OCTA product from the company Alamedics Gmbh was used during these two procedures.
Following similar incidents that occurred in Spain, the products present on the market were recalled, as a precaution, in France as of July 15, 2015 and distribution was stopped on that date. In France, 10 units were used among the 75 marketed since 2012.
At this stage, the accountability of the product has not been established for either case. It remains under investigation for one of the patients and has been formally ruled out by the surgeon in the other case.
The ANSM is currently conducting investigations in conjunction with the competent European authorities to determine the exact causes of these incidents.