LASIK Risks and Complications

The following outline summarizes LASIK risks that must be conveyed to the public

  • Safety problems (risks)
    • Adverse event percentages
      • Persistent adverse events, including dry eyes and night vision difficulties: >20%
      • Other problems: >1%
      • Sight threatening thinning and bulging of the cornea (keratectasia): at least 0.66%
    • Permanent pathology in cornea
      • LASIK flap
        • Never heals
        • May be accidentally dislodged for the rest of a patient’s lifetime
      • Mechanical strength of post-LASIK cornea only ~2% strength of normal cornea (this is specifically the flap interface)
      • Progressive loss of corneal cells for years after LASIK
      • Corneal nerve damage never fully recovers
    • Types of adverse events to expect
      • Glare, halos, dry eye and compromised night driving
      • Permanent loss of contrast sensitivity
      • Unstable vision
      • Permanent corneal haze
      • Permanent dry eye
      • Night time vision permanently impaired
      • Vision improvements from LASIK will likely decline with age
      • May require corneal transplant, expensive special hard contact lenses, or cross-linking treatment due to thinning and bulging of the cornea
      • Extreme light sensitivity
      • Potential future eye problems
        • Undiagnosed glaucoma
        • Poor outcome from cataract surgery
  • Benefits (effectiveness) – about 43% of LASIK cases may have temporary freedom from wearing spectacles or contact lenses

Morris Waxler PhD.

FDA’s chief scientist in charge of the clinical trials research for laser eye surgery, popularly known as LASIK.

Long term effects reported

  • Chronic Dry Eye*
  • Unrelenting Eye Pain
  • Visual Distortions*
  • Depression & Anxiety
  • Ectasia (loss of corneal structural integrity, resulting in a bulging cornea with associated vision loss which is not correctable with eyeglasses or soft contact lenses.)

The following outline summarizes LASIK risks that must be conveyed to the public

  • Safety problems (risks)
    • Adverse event percentages
      • Persistent adverse events, including dry eyes and night vision difficulties: >20%
      • Other problems: >1%
      • Sight threatening thinning and bulging of the cornea (keratectasia): at least 0.66%
    • Permanent pathology in cornea
      • LASIK flap
        • Never heals
        • May be accidentally dislodged for the rest of a patient’s lifetime
      • Mechanical strength of post-LASIK cornea only ~2% strength of normal cornea (this is specifically the flap interface)
      • Progressive loss of corneal cells for years after LASIK
      • Corneal nerve damage never fully recovers
    • Types of adverse events to expect
      • Glare, halos, dry eye and compromised night driving
      • Permanent loss of contrast sensitivity
      • Unstable vision
      • Permanent corneal haze
      • Permanent dry eye
      • Night time vision permanently impaired
      • Vision improvements from LASIK will likely decline with age
      • May require corneal transplant, expensive special hard contact lenses, or cross-linking treatment due to thinning and bulging of the cornea
      • Extreme light sensitivity
      • Potential future eye problems
        • Undiagnosed glaucoma
        • Poor outcome from cataract surgery
  • Benefits (effectiveness) – about 43% of LASIK cases may have temporary freedom from wearing spectacles or contact lenses

Read Dr. Waxler’s petitionRequest a Public Health Advisory with a voluntary recall of LASIK devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for LASIK eye surgery.

 

*A 2007 review of data from FDA clinical trials for LASIK devices, including newer custom wavefront technology, demonstrates that approximately 20% of patients report dry eyes and night vision problems persisting beyond six months after surgery.