The U.S. Food and Drug Administration (FDA) in February 2007 recalled all Alcon LADARVision 6000 excimer lasers used for LASIK laser eye surgery. This recall came after patients experienced an unusually high percentage of serious complications after this particular brand of laser was used for the procedure. During LASIK, an excimer laser reshapes the cornea of the eye and changes refractive error with the goal of correcting nearsightedness, farsightedness or astigmatism and 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, which was subject to the recall. The LADARVision 6000 was intended by Alcon to replace its prior generation surgical laser, the LADARVision 4000, which had its own unreliability issues.
Alcon’s LADARVision 6000 was being called the best in excimer laser technology when it was approved by the FDA in May 2006. But, shortly after the software upgrade was widely installed, LASIK clinics in the country reported patients developing vision problems after surgery known as “central islands.” Central islands are created by the uneven application of the laser’s energy, creating elevated spots or “islands.” Central islands can cause degradation in the quality of one’s vision and such deterioration may be permanent depending on the severity.
Several products liability actions filed against Alcon alleged that the company defectively designed the product and failed to correct defects which it knew or should have known would cause injury to patients. Plaintiffs also alleged that Alcon failed to notify the FDA about adverse outcomes and incidents and did not warn physicians about the defective product condition. Some doctors even sued the company claiming that the prior laser would remove too much eye tissue, would perform sporadically or erratically and had a high risk of failure or adverse incidents which consumers, the FDA or the medical community were not warned about.
If you or a loved one has suffered serious or catastrophic injury as a result of such defective products, or medical devices, you may be able to seek compensation to cover past and future medical expenses, disfigurement, lost earning capacity, mental anguish and physical pain and suffering. Please contact a LASIK eye surgery lawyer at the Law Office of Todd J. Krouner at (914) 238-5800 or email@example.com for a free, comprehensive and confidential consultation and evaluation of your claim.