Posts Tagged ‘lasik malpractice’

Nearly 1.4 million patients each year undergo Lasik surgery, which is now a $2 billion industry.  Last week, however, the FDA recognized that it had little to no information about adverse life events from people who are undergoing Lasik surgery.  The reason is not the lack of events, but most likely because the adverse events are not reported.  The FDA, the Defense Department and the National Eye Institute are teaming up to run a three-year program to gauge how many Lasik surgery patients suffer from post-Lasik operation problems.  The FDA’s press relase regarding the FDA’s Quality of Life Project can be found here along with information about how to report Lasik related probelms and side effects.

At the same time as the FDA announcement last week about the quality of life program, the FDA issued warning letters to 17 Lasik sugery centers who accept walk-in patients reminding them of their obligation to report poor outcomes and any surgery-related medical complaints from patients who have Lasik surgery at their facilities.  The letters were issued after FDA inspections of the facilities found that they had no system for collecting and transmitting to the FDA data on patients’ reports of post surgical “adverse events.”

The FDA website provides a number of helpful resources about Lasik surgery, including a Lasik surgery checklist (which should help patients avoid Lasik malpractice), which includes various tips and other advice for those considering Lasik surgery, such as:

Know what makes you a poor candidate

Career impact - does your job prohibit refractive surgery?
Cost - can you really afford this procedure?
Medical conditions - e.g., do you have an autoimmune disease or other major illness? Do you have a chronic illness that might slow or alter healing?
Eye conditions - do you have or have you ever had any problems with your eyes other than needing glasses or contacts?
Medications - do you take steroids or other drugs that might prevent healing?
Stable refraction - has your prescription changed in the last year?
High or Low refractive error - do you use glasses/contacts only some of the time? Do you need an unusually strong prescription?
Pupil size - are your pupils extra large in dim conditions?
Corneal thickness - do you have thin corneas?
Tear production - do you have dry eyes?

Know all the risks and procedure limitations

Over-treatment or under-treatment - are you willing and able to have more than one surgery to get the desired result?
May still need reading glasses - do you have presbyopia?
Results may not be lasting - do you think this is the last correction you will ever need? Do you realize that long-term results are not known?
May permanently lose vision - do you know some patients may lose some vision or experience blindness?
Dry eyes – do you know that if you have dry eyes they could become worse, or if you don’t have dry eyes before you could develop chronic dry eyes as a result of surgery?
Development of visual symptoms - do you know about glare, halos, starbursts, etc. and that night driving might be difficult?
Contrast sensitivity - do you know your vision could be significantly reduced in dim light conditions?
Bilateral treatment - do you know the additional risks of having both eyes treated at the same time?
Patient information - have you read the patient information booklet about the laser being used for your procedure?

Know how to find the right doctor

Experienced - how many eyes has your doctor performed LASIK surgery on with the same laser?
Equipment - does your doctor use an FDA-approved laser for the procedure you need? Does your doctor use each microkeratome blade only once?
Informative - is your doctor willing to spend the time to answer all your questions?
Long-term care - does your doctor encourage follow-up and management of you as a patient?  Your preop and postop care may be provided by a doctor other than the surgeon.
Be comfortable - do you feel you know your doctor and are comfortable with an equal exchange of information?

Know preoperative, operative, and postoperative expectations

No contact lenses prior to evaluation and surgery - can you go for an extended period of time without wearing contact lenses?
Have a thorough exam - have you arranged not to drive or work after the exam?
Read and understand the informed consent - has your doctor given you an informed consent form to take home and answered all your questions?
No makeup before surgery - can you go 24-36 hours without makeup prior to surgery?
Arrange for transportation - can someone drive you home after surgery?
Plan to take a few days to recover - can you take time off to take it easy for a couple of days if necessary?
Expect not to see clearly for a few days - do you know you will not see clearly immediately?
Know sights, smells, sounds of surgery - has your doctor made you feel comfortable with the actual steps of the procedure?
Be prepared to take drops/medications - are you willing and able to put drops in your eyes at regular intervals?
Be prepared to wear an eye shield - do you know you need to protect the eye for a period of time after surgery to avoid injury?
Expect some pain/discomfort - do you know how much pain to expect?
Know when to seek help - do you understand what problems could occur and when to seek medical intervention?
Know when to expect your vision to stop changing - are you aware that final results could take months?
Make sure your refraction is stable before any further surgery - if you don’t get the desired result, do you know not to have an enhancement until the prescription stops changing?

If you have undergone Lasik surgery and believe that you may be a victim of Lasik malpractice, contact a Lasik malpractice lawyer today for a free and confidential legal evaluation at info@consumerinjurylawyers.com or (877) 779-1414.

Using contact solution correctly and safely is key to keeping your eyes healthy.  For example, not emptying the solution out of your contact lens case after each use could cause serious injures and even blindness from an infection.  Solutions that are not thrown out after use are essentially “dirty” and can contain various bacteria and micro-organism. Using fresh and clean solution each time reduces the risk of getting eye infections.

The FDA recently published an article on the importance of using contact lens solution correctly and safely.  The article discusses the Dos and Don’ts for contact lens wearers, how to prevent eye infections, and the symptoms of eye infections. In January 2009, the FDA assembled a workshop called “Microbiological Testing of Contact Lens Solution Products,” in collaboration with several eye care professional groups.  The workshop’s goal was to gain consensus on test methods for evaluating contact lens solutions and the development of Acanthamoeba keratitis, a rare but serious eye infection.  The FDA also convened a meeting of its Ophthalmic Device Panel in June 2008, to identify ways to improve contact lens safety. The panel gave updated information about keeping contact lens care products safe. Currently, the FDA is revising the guidance document, which specifically addresses the labeling and directions for proper use of contact lens solutions.

The FDA stresses the importance of not using contact lens solution more than once, not using expired solution, and rubbing and rinsing your contacts thoroughly with clean and fresh solution daily. Failure to use contact lenses and solution correctly can cause eye infections.  Both bacterial and fungal infections can lead to serious consequences, such as permanent loss of sight if left untreated.  Bacterial infections are more common than fungal infections, but fungal infections are much more difficult to diagnose and treat.  If left untreated, fungal infections can cause permanent blindness, sometimes within as little as 24 hours.  Symptoms of eye infections include, but are not limited to: discomfort, excess tearing or other discharge, unusual sensitivity to light, itching, burning, and pain.

The FDA became increasingly aware of the potential danger of not monitoring the safety of contact lens solutions closely after the Advanced Medical Optics’ (AMO) voluntary recall of Complete MoisturePlus contact lens solution.  The Center for Disease Control and Prevention identified a link between Complete MoisturePlus and the onset of Acanthamoeba keratitis, which caused blindness in several Complete MoisturePlus users. AMO speculated that improper handling and shipping of Complete MoisturePlus solutions caused this outbreak.

Some people avoid the hassle and dangers of wearing contact lens by opting to get lasik surgery to permanently correct their visions.  However, even though the technology for lasik surgery has improved over the years, there are still risks involved in lasik surgery.  If you or a loved has been injured by lasik surgery, you may have a lasik malpractice lawsuit and should contact a lasik malpractice lawyer today.

On June 10, 2009, a New York City jury found Dr. Kevin Niksarli liable to Johnson Devadas for $2,360,000 in lost income and $3,1000,0000 for pain and suffering after Dr. Niksarli committed Lasik malpractice.  Dr. Niksarli wrongly decided that Mr. Devadas was a candidate for Lasik surgery.  The jury also awarded Saramma Devaddas $120,000 for her lost consortium claim.  The total award was for nearly $6 million.  Mr. Devadas is a pharmacists from Queens, New York.  Judge Doris Ling-Cohan presided over the trial in New York County Supreme Court.  The Lasik malpractice verdict is reported to be the second largest New York Lasik malpractice verdict in history and possibly the largest Lasik malpractice verdict in United States in history.

The Lasik malpractice trial lasted about 10 days and the plaintiff presented evidence through experts that he was in fact misdiagnosed as a candidate for Lasik surgery.  His experts claimed he suffered from fruste keratoconus, which is contraindicated for Lasik surgery candidates.  After the Lasik surgery, the plaintiffs cornea developed post-Lasik ectasia, which is a progressive thinning of the cornea.  Ectasia can cause blurriness, halos, double vision, glare, contrast sensitivity, starbursts and other problems over the distortion of light passing through the damaged cornea.

Perhaps most alarming and what may have helped justify the significant verdict, plaintiffs presented evidence that Dr. Niksarli intentionally and artifically aged a note in his chart concerning a conversation he allegedly had with the the plaintiffs concerning the risks, benefits and the alternatives to Lasik surgery.