Their review of the problems with LASIK will be divided into three phases. The first phase, which began in July, was the design and implementation of a web-based questionnaire for LASIK patients, which focuses on quality of life problems after LASIK surgery. The second phase will focus on determining quality of life for active military personnel who have undergone LASIK at the Navy Refractive Surgery Center. The final phase will be a similar clinical trial on the general population, which is expected to end in 2012.

LASIK is a form of eye surgery that uses a laser to improve a patient’s vision and reduce their need to wear glasses or contact lenses. During the eye surgery, a surgical instrument known as a microkeratome is used to cut through the top layers of the cornea to create a flap. A laser beam is then used to reshape the cornea for vision correction and the corneal flap is replaced.

A 2008 American Journal of Ophthalmology report found that additional surgeries were needed for 28% of the eyes treated with LASIK less than 10 years after the initial surgery, due to undercorrection, overcorrection, or regression.

Reports of LASIK problems commonly involve double vision, halos around objects at night and dry eyes. In more severe cases, complications can have a severe impact on an individual’s quality of life.

The FDA hopes that the results of the study will help the agency understand the adverse effects of LASIK, and identify means to reduce the risks for future patients. However, the study also may result in new regulations on the safe use of LASIK if the FDA deems necessary.

In addition to the study, the FDA also announced that it has sent warning letters to 17 LASIK eye surgery centers. The warnings came after FDA inspectors discovered inadequate systems for reporting adverse events suffered by LASIK patients at the centers. Legislation passed in 1990 makes it a requirement that medical facilities of all kinds report all device-related serious injuries or deaths related to the FDA and the device manufacturer.

Although rare, a number of patients have filed Lasik surgery malpractice lawsuits against eye surgeons for complications that were allegedly caused by a failure to follow the appropriate standard of medical care, most commonly involving problems that occur after a doctor fails to properly screen patients out as a potential candidate for the eye surgery.

The warning comes in the wake of FDA hearings held in April 2008 that addressed many of the Lasik risks and complaints of former patients who experienced problems after Lasik eye surgery.

LASIK (laser-assisted in-situ keratomileusis) is a form of corrective eye surgery that uses a laser to improve a patient’s vision and reduce their need to wear glasses or contact lenses.

During the eye surgery, a surgical instrument known as a microkeratome is used to cut through the top layers of the cornea to create a flap. A laser beam is then used to reshape the cornea for vision correction and the corneal flap is replaced.

“The FDA has received complaints that eye care professionals’ advertisements for LASIK procedures and FDA-approved lasers used for the LASIK procedures failed to inform consumers of the indications, limitations, and risks associated with LASIK procedures and the approved lasers used for the LASIK procedures,” the FDA letter states.

The FDA has set up a special section of its website for consumers about potential problems with LASIK and other information to help consumers make a decision about whether the procedure is right for them.

According to the information posted by the FDA, the following Lasik risks should be considered before undergoing corrective eye surgery:

• Vision loss that cannot be corrected with glasses, contact lenses or additional surgery
• Debilitating visual symptoms such as glare, halo and/or double vision that can seriously effect vision at night or in fog
• Undertreatment or overtreatment may result in a failure to achieve 20/20 vision, and additional treatment may not be possible. Therefore, patients may still require glasses or contact lenses after srugery.
• Dry eye syndrome may occur, which could prevent the eye from developing enough tears, causing discomfort and reduced visual quality.
• Results are generally not as good in patients with very large refractive errors.
• Results may diminish with age for some farsighted patients.
• Long-term data is not available, as the first laser was approved for LASIK eye surgery in 1998.

The known risks of Lasik surgery have, so far, not been included in most advertisement, critics argue. Additionally, a 2008 American Journal of Ophthalmology report found that additional surgeries were needed for 28% of the eyes treated with LASIK less than 10 years after the initial surgery, due to undercorrection, overcorrection, or regression.

Lasik surgery malpractice lawsuits have been brought against eye surgeons for failing to follow the appropriate standard of care, most commonly for problems that develop after a doctor fails to properly screen a patient out as a potential candidate for the eye surgery.

STATUS OF LASER EYE SURGERY LAWSUITS: Medical malpractice lawsuits have been successfully brought against eye surgeons for carelessness during pre-surgery screening, incorrect operation of equipment during the procedure and negligent post-operative follow up.

>>REVIEW A POTENTIAL LASIK LAWSUIT WITH AN ATTORNEY<<

OVERVIEW: LASIK, which stands for laser-assisted in-situ kerastomileusis, is a form of eye surgery that uses a laser to improve a patient’s vision and reduce their need for glasses or contact lenses.

During the eye surgery, a surgical instrument known as a microkeratome is used to cut through the top layers of the cornea to create a flap. A laser beam is used to reshape the cornea for vision correction and the corneal flap is replaced.

Although advertisements often minimize the risks associated with Lasik, a 2008 report in the American Journal of Ophthalmology found that re-surgery was needed on 28% of eyes treated with LASIK in the last 10 years due to undercorrection, overcorrection or regression.

LASIK PROBLEMS: Nearly all LASIK surgery procedures are paid out of the pocket of the consumer, and the process has developed into more of a sales process than a medical consultation.

Potential patients often meet with a counselor who is not medically trained to determine if they are a candidate for laser eye surgery, and are usually not fully informed of the risks until after they have paid money out of their pocket and are far along in the pre-surgery process.

Unfortunately, many patients who undergo LASIK procedures are not ideal candidates, and could be left with serious and often disabling vision problems that they were not properly warned about. Reported Lasik problems, which could be linked to a medical mistake before, during or after the eye surgery, include:

• Blurry Vision
• Double Vision
• Scarring of the Cornea
• Dry Eyes
• Sensitivity to Light
• Halo or Starburst Effects at Night
• Loss of Vision

While the extent of these problems can vary, some patients are unable to conduct many of the day-to-day activities they used to be able to perform, are left with headaches and depression, and severe quality of life loss.