WASHINGTON DC / February 21, 2007 / All US Alcon LADARVision
6000 excimer lasers used for the popular Lasik laser eye surgery
have been affected by an FDA recall after patients experienced an unusually
high percentage of serious complications. An excimer laser
reshapes the cornea of the eye during Lasik and changes refractive
error with the intended purpose of reducing the patient's need for
glasses or contact lenses.
The LADARVision 6000 CustomCornea software algorithm installed
in the laser platform is the component of the device recalled. Only
the algorithm has been recalled, not the entire LADARVision 6000
laser. The LADARVision 4000 laser, predecessor to the LADARVision
6000, is not affected by the recall.
The LADARVision 6000 was heralded as the best in excimer laser
technology when approved by the FDA in May 2006, however shortly
after the software upgrade was widely installed, US Lasik clinics
reported patients developing central islands after surgery. Central
islands are areas of the cornea that do not receive the required
amount of laser energy, creating elevated spots or "islands". Central
islands can cause a degradation in vision quality that may
be permanent. Symptoms of central islands are normally immediately
noticeable by the patient.
Read our detailed article about
Lasik Central Islands. Patients with additional questions can
call the Alcon toll free at 1-877-523-2784.
