The Food and Drug Administration (FDA) is charged with ensuring safety of medical devices, such as lasers used in LASIK eye surgery. The FDA tracks problems with LASIK through its MedWatch program.
Since the inception of LASIK, surgeons have downplayed or ignored complications such as chronic dry eyes and night vision difficulty (starbursts, halos, multiple images, and loss of contrast sensitivity) and have failed to report these problems to the FDA. The FDA recently affirmed that these problems are adverse events which should indeed be reported:
... "an emphasis that halos, glare, night vision problems and dry eye from LASIK should be reported to FDA." http://www.fda.gov/cdrh/lasik/latest.html
In October, 2008, the American Academy of Ophthalmology (AAO) published a new LASIK Patient Guide. In the section titled "Sample Informed Consent", the guide lists starbursts, halos, low-light vision problems, and difficulty driving at night as "NON VISION THREATENING SIDE EFFECTS".
LASIK patients who suffer from these complications would disagree with this assessment. Many patients report severe visual impairment, such as inability to drive at night. Loss of dim-light vision may also lead to problems with employment and diminished quality of life.
With publication of the new 'LASIK Patient Guide', it seems that the intent of the LASIK industry is to continue to deceive prospective patients concerning the nature, incidence and severity of LASIK-induced complications. Until the LASIK industry is forced to acknowledge night vision problems as adverse events, and that loss of contrast sensitivity represents systematic and quantifiable LASIK-induced vision loss, they will likely continue to ignore FDA reporting requirements.
