LASIK Eye Surgery Defined
Laser-Assisted in Situ Keratomileusis or LASIK is a surgical method that can lower the dependence of an individual to eye glasses or contact lenses. The method will permanently alter the form of the cornea, the fragile part of the eyes that cover the front of the eyes. The cornea and lens of the eyes must bend or refract properly to have the images focused on the retina and have a clear vision. If the light rays are not properly and clearly focused, it can cause blurry or hazy eyesight.
The LASIK eye procedure is usually done on individuals who are nearsighted, an eye condition called as myopia. LASIK is an outpatient surgical method that takes for about 10 to 15 minutes for every eye.
How FDA Regulates LASIK
The US Food and Drug Administration control the sale of the medical equipment and devices such as the lasers being used for the LASIK eye surgery. The individual or company must obtain the approval of the US FDA before they can legally sell a medical equipment or device in the US. The applicant must submit evidence that the device is safe and effective for a specific use or the “indication.” Then, the surgeon may decide to apply medical equipment or device which is granted approval by the US FDA for other indications for the best interest of the patient. But the FDA cannot regular the use of “off-label use” or the practice of medicine. Hence, US FDA cannot
Who Must Not Use LASIK Eye Surgery?
You may not be a good patient for the LASIK procedure if:
Your healthcare provider should examine the following conditions or indicators of the potential risks before the LASIK procedure:
- Inflammation of the eyelids with crusting of the eyelashes or an eye condition known as blepharitis
- Thin corneas
- Big pupils
- Dry eyes
- History of refractive surgery including LASIK, RK, or PRK
What should I tell my healthcare provider?
Before undergoing LASIK procedure, inform your healthcare provider if you have some history of any of the following conditions:
- Glaucoma, glaucoma suspect, ocular hypertension
- Herpes simplex, herpes zoster or shingles around the areas of the eyes
- Eye illnesses like uveits/iritis or inflammation of the eyes
Health Risks from LASIK
Most of the patients are satisfied with the results of the LASIK and other refractive surgery, but there are still health risks that are involved. The following are some of the risks that should be thoroughly considered against the benefits of the LASIK eye surgery:
Obtaining Legal Assistance
Since the application and use of equipment and devices for the surgical methods have their particular potential risks, it is the obligation of the manufacturer to produce products that are safe and inform the medical community and the general public of its known risks related to their products. If the manufacturer was unable to do these, then they will be held liable if the patients who are injured of inadequate warning or the hazardous nature of the products, under the legal theory which is called as “product liability.”
If you or any of your family members have suffered any health effects or rare medical conditions after undergoing the LASIK or other refractive procedures, you should contact first your doctor or healthcare provider. Then, you may look for an experienced lawyer to discuss with you options and safeguard your legal rights for treatment of any injury caused by the LASIK eye surgery.