FDA Update: Ophthalmic Device Panel Meeting To Review LASIK Safety

LASIK Safety Review

On April 25, 2008, the committee will discuss general issues concerning the experience and quality of life of patients who have had LASIK.

How Serious is the Problem?  Are the Patients Going Blind?

Dr. Daniel Schultz, director of FDA’s Center for Devices and Radiological Health, said a number of concerns have been raised concerning patient satisfaction with LASIK.

Companies that could be affected by such a meeting include LASIK device makers such as Advanced Medical Optics Inc, as well as LASIK providers such as TLC Vision Corp and LCA-Vision Inc.

Obviously, it’s a technology that has caught on and is used very, very widely. And there have been questions raised in terms of … quality of life and what does it actually do for the patient as opposed to the technology itself,” Schultz told reporters.  Shultz said the meeting will focus on the quality of patients’ lives after surgery.

Known complications from the procedure can include dry eyes, glare, double vision, an increased risk of corneal inflammation or infection, and blindness.

Patients Call for Ban: In July 2007, the FDA responded to petitions from an individual asking for a halt to the procedures and a withdrawal of their approval. The agency said the devices were safe and effective but advisory panel discussions “could complement” its other safety monitoring.

The Boston Globes writes on the adverse effect of the current economic downturn on Lasik numbers and the potential adverse effect of this meeting on Lasik businesses.

But the declining U.S. economy continues to impact the number of laser vision correction surgeries, and Biegelsen cautioned investors that the outcome of the upcoming FDA Lasik advisory committee meeting on April 25 will likely be neutral at best.

“A best case scenario is little-to-no negative headlines in the media and the panel endorses the long safety of Lasik and encourages further use of femtosecond lasers,” he wrote in a note to clients. “On the downside, negative media coverage of unhappy Lasik patients and a panel recommendation to narrow the indications could drive volume down further. We think the most important variable is the media coverage which tends to be negative.”