Safety Information

Indications for Use:

The KAMRA inlay is indicated for intrastromal corneal implantation to improve near vision by extending the depth of focus in the non-dominant eye of phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0.50 diopters (D) to -0.75 D with less than or equal to 0.75 D of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.00 D to +2.50 D of reading add.

Summary of Important Information:

  • The KAMRA inlay procedure may not eliminate the need for reading glasses.
  • The KAMRA inlay procedure may cause blurred vision, difficulties with contrast sensitivity, problems with night vision, double vision, ghost images, glare, halos, and color disturbances. Your eye may also feel pain, dryness, burning, discomfort and look red.
  • Other risks you may experience include infection, swelling, thinning, or inflammation of the cornea, and changes in your vision.
  • The KAMRA inlay CAN be removed. During the clinical study, after removal of the inlay, vision generally returned to the level the patient had prior to the implantation with the KAMRA inlay. However, this does not guarantee that your vision will return to exactly what it was before surgery or that your eye will not have permanent damage.
  • Non-surgical alternatives to the KAMRA inlay procedure include the use of reading glasses or contact lenses.
  • Before considering the KAMRA inlay procedure you should: 1) Have a complete eye examination and, 2) Talk with your eye surgeon about the alternatives to treatment, potential benefits, complications, risks, and time required for healing.

Note: The KAMRA inlay contains no metal and is compatible with both T1 and T2-weighted magnetic resonance imaging (MRI).

Precautions:

If you’re planning to have any additional surgeries please let your doctor know that you have a KAMRA inlay.

  • The inlay should be removed before any laser glaucoma procedure.
  • During Nd:YAG procedures, direct the laser beam around the periphery of the inlay.
  • The creation of a LASIK flap using a femtosecond laser with the inlay in place in the cornea is not recommended.
  • The inlay should be removed prior to performing any unfocused laser photocoagulation procedure of the retina or over posterior segment tissue.

Note: The KAMRA inlay contains no metal and is compatible with both T1 and T2-weighted magnetic resonance imaging (MRI).

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