LASIK is a type of refractive surgery in which a surgeon reshapes the cornea to change its optical power. This is done by using an excimer laser and performed by a certified LASIK eye surgeon. The procedure aims to make the patient less dependent on using eyeglasses and contact lenses. Because the procedure involves the use of an excimer laser machine, the question of the machine’s safety then arises.
The U.S. Food and Drug Administration
According to the U.S. FDA website, their primary role is to regulate the sale of medical devices and to subsequently monitor their safety. The FDA regulates the sale of all medical devices such as lasers used for LASIK. In fact, before a certain seller is able to legally sell a medical device in the U.S., he must seek approval from the FDA first. And, to do so, they must present evidence that the device is reasonably safe and effective. The FDA also monitors the ongoing safety and efficacy of all regulated marketed devices, through problem reporting programs.
An Ongoing Process of Monitoring
The FDA must first approve any excimer laser machine prior to its use. In fact, the machines are already monitored even before purchase and transfer to different clinics and hospitals. However, the FDA’s role does not end there. The department also conducts programs that aim to constantly evaluate the safety and efficacy of already approved machines. You can be sure that if a clinic or hospital is using an FDA-approved laser machine, it is also regularly FDA examined. Otherwise, if the medical practice fails to comply with these guidelines, regulatory actions may ensue. Examples of these sanctions are seizure, injunction, and civil money.
The FDA Website
Also, the FDA website itself has information that covers everything a LASIK candidate needs to know about the procedure. Some of the information that the website offers includes what a patient should know before the surgery, what will happen while the surgery is ongoing, and what the patient should expect after undergoing the surgery. A checklist of issues for you to consider, practices to follow, and questions to ask your doctor is also available.
What You Should Know
After discovering that the LASIK machine is FDA-approved, you can then look for the right surgeon to perform the procedure. The FDA checklist also includes some criteria which serve as a guide in looking for the right LASIK surgeon. Some considerations are: How many eyes has your doctor performed LASIK surgery on with the same laser? Does your doctor use an FDA-approved laser for the procedure you need? Is your doctor willing to spend the time to answer all your questions? Does your doctor encourage follow-up and management of you as a patient? Does your doctor tell you how to keep your eyes healthy? Do you feel you know your doctor and are comfortable with an equal exchange of information?
Now, we are ascertained that the FDA truly upholds maintaining safety in all aspects of the LASIK procedure. We can also be more confident that our future LASIK surgery will be a safer and more pleasant experience too.
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