Angle-supported phakic IOLs withdrawn from the French market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.

The study, which was retrospectively carried out at several centers in France, confirmed the high incidence of the complication 2 to 3 years after implantation for both types of phakic IOLs. Among 2,324 implants, 27 were removed due to significant endothelial cell loss.

Although less significant, a similar risk was also found with the implantation of the myopic GBR/Vivarte, with 15 explantations out of 4,033 cases.

Therefore, it was decided to withdraw the lenses from the market, which became official in January.

"Evaluation of the endothelial cell count every 6 months after implantation of all anterior chamber phakic IOLs is mandatory," said an official letter sent to all ophthalmology departments by Pascal Bernard, director of research of IOLTech. "If a decrease of more than 30% of corneal endothelial cells or a rate of less than 1,500 cells/mm² is observed, explantation is recommended."

Surgeons were again invited to report all cases of significant endothelial cell loss and phakic IOL removal to local health authorities.

Cornéal is following a similar path with the Icare phakic IOL for high myopia and announced, in accordance with the AFSSAPS, the temporary withdrawal of the Icare lens from the market until the results of a retrospective study provide more reliable information on the safety of this implant

In a letter sent in March to all ophthalmology departments, Philippe Sourdille, MD, medical director of Cornéal, mentioned seven cases of explantation due to endothelial cell loss. Ophthalmologists were recommended to monitor their patients' endothelial cell counts every 6 months.

Also with the Icare implant, the decrease in endothelial cells seems to occur suddenly, after 2 to 3 years of stability. The cause of this complication has not yet been found for any of the angle-supported lenses.