This article is more than 5 years old. Information may no longer be current.
LADAR6000 algorithms for myopia treatment deactivated
Click Here to Manage Email Alerts
Alcon has officially completed the deactivation of two algorithms used for CustomCornea treatment of myopia with or without astigmatism, the U.S. Food and Drug Administration announced.
The algorithms were recalled in February in response to reports of corneal abnormalities or "central islands" that may not be correctable with laser therapy. Use of the algorithms has also been linked with a decrease in visual acuity that may not be correctable with glasses or contact lenses, the FDA said.
Health care professionals were notified of the problem in a Feb. 21 letter and recall notice and were directed to no longer use the LADAR6000 units to perform CustomCornea LASIK for myopia. On May 11, they were advised by the FDA that Alcon would be willing to deactivate the device's ability to perform these procedures.
The recalled algorithms have now been deactivated in all LADAR6000 units in the United States, the FDA said. Approximately 102 systems were distributed nationally between Aug. 17, 2005, and Feb. 21, 2007. Eighteen are held in Alcon's possession, and two are being held by a freight handler.
In its most recent earnings report, Alcon said it has "submitted a pre-market authorization supplement to the FDA with proposed corrective actions to the machine."
Company officials have declined to discuss whether plans for a re-launch are in the works.
"There has been no new movement with the FDA and no agreement to get the algorithms back online," Kathleen Golden, a senior specialist in corporate communications at Alcon, told Ocular Surgery News this week.
The recall, categorized by the FDA as a class 1 recall, is limited to the algorithms and not the device itself.