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Medical Devices

Eyeing Perils of LASIK Surgery



Center for Devices and Radiological Health
Food and Drug Administration Rockville, Md.

A man considering laser-assisted in-situ keratornileusis (LASIK) surgery, which is done to correct nearsightedness or astigmatism, asked the ophthalmologist about possible complications. The physician told him they occur in rare cases but go away naturally or can be corrected by follow-up "enhancements." He said the man was an ideal candidate for surgery.  

The man had LASIK surgery on each eye. More than10 months and one enhancement afterward, his vision was still very poor, plus he had blurring, double vision, and ghost images he hadn't had before surgery. 

Although the LASIK procedure is relatively safe, complications can occur. Having received reports of resulting eye injuries and complications, the FDA looked into the issue and launched a Web site to bring unbiased information to consumers. If your patient is considering LASIK surgery, tell him to take these precautions:

  • Do a literature search to learn about LASIK surgeryand possible complications.
  • Learn more at the FDA Web site,
  • Do a Web search to learn about firsthand experiences of people who've had LASIK surgery.
  • Research LASIK surgeons and pick someone with a lot of experience and good results. Take a list of questions to your first appointment. (See below.) 
What to ask your health care professional:
  • How many LASIK procedures have you performed?
  • What are the possible complication?
  • Am I at high risk for any of them?
  • What are the most common complications patients in your practice have experienced?
  • How do you treat complications?
  • What’s my pupil size? Does it represent a high risk for complications? (See “When is LASIK not for me” at the FDA Web site.)
  • What type of LASIK machine do you use? Is it FDA approved?

Page Last Updated: 08/05/2015
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