Alcon recalls LADARWave software

Alcon has initiated a recall of the software in 157 LADARWave CustomCornea units due to a software error that may lead to ophthalmologists’ retrieving patient data incorrectly, according to the Food and Drug Administration.

The FDA noted the recall was company-initiated, and affects the aberrometer software version 7.91 in Alcon’s LADARVision System. According to the FDA information, the software error “could, under specific circumstances, allow the patient’s centration images and data to be stored incorrectly.”

According to an Alcon spokesperson, the company sent out a safety alert to all LADARWave owners last month. “We didn’t ask anything to be returned,” Mary Dulle, corporate communications director, told Ocular Surgery News. The software glitch, she said, is in the “sort by” function.

“We’re asking users not to sort patient data by ‘sort by first name’ or ‘sort by last name’,” she said. Searching by patient name or medical record is unaffected by the glitch, she added.

Ms. Dulle added that of the 109 domestic units affected, every ophthalmologist is in receipt of the letter and has sent back information saying they’ve read the safety alert and taken appropriate precautions. Internationally, 42 of 48 sites have responded affirmatively, Ms. Dulle noted. “We are making every effort to contact the remaining sites to alert them as well,” she said.

Alcon is debating whether to reprogram the “sort by” feature or eliminate it completely on future versions of its software.

Daniel S. Durrie, MD, told Ocular Surgery News “there are several other checks in the actual procedure that would avoid actually treating the wrong eye. I am unaware of any patient problem and it has not affected patient treatment here at all.”