Adverse Events and Complications
Some patients experienced adverse events and complications after CustomVue™ LASIK treatment Flap complications ( less than 1%)
• Incomplete or irregular flap creation
• Scratch on the surface of the eye with microkeratome
• Inflammation of the cornea under flap
• Wound infection Visual symptoms and problems Some patients experience these symptoms and problems during first to sixth months after LASIK due to corneal healing and remodeling. Severity and risk of having such problem permanently depends on pre operative eye conditions.
• Dry eyes
• Blurry of vision
• Fluctuation of vision
• Difficulty at night with glare
• Halos ( hazy rings around bright lights)
• Ghost or double images
What Warnings and Other Information Do You Need to Know About?
Warnings
If you have more severe nearsightedness or astigmatism, your results may not be as good as those reported in this clinical study. If you have any of the following conditions, you may have LASIK if your doctor evaluates the seriousness of your condition and believes the benefit of having LASIK is greater than the risk.
• Diabetes. If you have diabetes, LASIK may be risky for you because your diabetes may interfere with the healing of your eyes.
• History of Herpes simplex or Herpes zoster infection that has affected your eyes. If you have had a Herpes simplex or a Herpes zoster infection that affected your eyes, and have an infection now, LASIK is more risky for you. Pre-medication is recommended to decrease risk.
• Symptoms of significant dry eye. If you have severely dry eyes, LASIK may increase the dryness. This may or may not go away. This dryness may delay healing of the flap or interfere with the surface of the eye after surgery.
Precautions
It is unknown whether LASIK is safe and effective for the following conditions.
You should discuss these conditions with your doctor:
• Unstable eyes that have changed in their visual acuity more than 0.5 diopters in nearsightedness or astigmatism in the last 12 months, and your nearsightedness or astigmatism is getting worse. If your eyes are unstable, the right amount of treatment cannot be determined. This may result in poor vision after LASIK.
• Corneal disease or abnormality (e.g., scar, infection, etc.). If you have an abnormal corneal condition, such as corneal scars, because it may affect the accuracy of the LASIK treatment or the way your cornea heals after LASIK. This may result in poor vision after LASIK. If your eyes have an active disease, it is unknown whether LASIK is safe and effective under this condition.
• History of injury or surgery to the center of the cornea (for example, surgery to correct vision such as RK, PRK, LASIK), or other surgery on the eye. If your eyes are injured or you have had surgery, it is unknown whether LASIK will weaken the cornea too much.This may result in poor vision after LASIK.
• Corneas are thin. If your corneas are too thin to allow your doctor to cut a proper flap in the LASIK procedure, you can’t have LASIK because it is necessary to have a flap.
• History of glaucoma or have had pressure greater than 23 mmHg inside your eyes, because it is unknown whether LASIK is safe and effective for you.
• Take medicines that might make it harder for wounds to heal, such as Sumatriptan (Imitrex®*) used for migraine headaches, because it is unknown whether LASIK is safe and effective for this condition.
• Undiagnosed dry eyes. Your doctor should also evaluate you for dry eyes before surgery. You may have dry eyes after LASIK surgery even if you did not have dry eyes before surgery.
• Large pupils. Before surgery, your doctor should measure your pupil size under dim lighting conditions.
• Dim lighting, rain, snow, fog, or bright glare. You might have difficulty seeing in dim lighting, rain, snow, fog, or bright glare. Whether you may have poor vision under these conditions is hard to predict because it has been studied so little.
• Any other medications you are taking. Let your doctor know if you taking any prescription medicines or any medicines you bought without a prescription. |
