Angle-supported phakic IOLs banned in France

August 23, 2007

Angle-supported phakic IOLs can no longer be sold or implanted in France because of their association with significant endothelial cell loss, which was discovered in patients two to three years after implantation.

Angle-supported phakic IOLs can no longer be sold or implanted in France because of their association with significant endothelial cell loss, which was discovered in patients two to three years after implantation.

Manufacturers, IOLTech/Carl Zeiss Meditec and Corneal have withdrawn the Vivarte and NewLife phakic IOLs and the Icare lens, respectively, in accordance with the French Agency for Sanitary Safety of Health Products (AFSSAPS) orders.

A retrospective study was organized to determine the incidence and cause and it was found that, out of 2,324 lenses implanted, 27 had to be removed because of significantly high cell loss.