OSN SuperSite Top Story 6/7/2007

http://www.osnsupersite.com/view.asp?rid=22220

Angle-supported phakic IOLs withdrawn from the French market

Angle-supported phakic IOLs will no longer be sold and implanted in France due to an alarming amount of endothelial cell loss found in a significant number of patients 2 to 3 years after implantation.

Manufacturers IOLTech/Carl Zeiss Meditec and Corneal, in accordance with the French Agency for the Sanitary Safety of Health Products (AFSSAPS), ordered the withdrawal from the market of the Vivarte and NewLife phakic IOLs (both IOLTech/Carl Zeiss Meditec) in January and the Icare lens (Cornéal) in March.

An alert was first raised in February 2006, when a warning note was distributed by the manufacturers of the NewLife and Vivarte presbyopic IOLs to all ophthalmology departments. The document mentioned cases of "explantation of these lenses due to endothelial cell loss, occurring 2 to 3 years after implantation." It also announced a retrospective study to determine the incidence and causes of this late complication.

Commercialization of the NewLife and Vivarte presbyopic lenses was temporarily suspended while the manufacturers waited for the study results. In the meantime, yearly examinations of the corneal endothelium and endothelial cell counts were recommended for all patients who had been implanted. Surgeons were also required to report all cases of endothelial cell loss to the authorities.