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INDICATIONS FOR USE AND SUMMARY OF IMPORTANT INFORMATION FOR THE RAINDROP® NEAR VISION INLAY

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

ATTENTION: Please see Professional Use Information and/or Patient Information Brochure for a complete list of Potential Risks, of Indications and Warnings and Precautions.

INDICATIONS FOR USE: The Raindrop® Near Vision Inlay is indicated for intrastromal implantation to improve near vision in the non-dominant eye of phakic, presbyopic patients, 41 to 65 years of age, who have manifest refractive spherical equivalent (MRSE) of +1.00 diopters (D) to -0.50 D with less than or equal to 0.75 D of refractive cylinder, who do not require correction for clear distance vision, but who do require near correction of +1.50 D to +2.50 D of reading add.

SUMMARY OF IMPORTANT INFORMATION

The Raindrop® Near Vision Inlay may not eliminate the need for reading glasses.

Implantation of the Raindrop® Near Vision Inlay has the potential to cause vision and eye symptoms; dry eyes; decreased vision; decreased contrast sensitivity; problems with the cornea, such as clouding, thinning, scarring, and inflammation; eye infection; increased eye pressure; and the need for another eye surgery, such as removal or replacement of the inlay, or other treatment.

You should not have the Raindrop® Near Vision Inlay implanted if you have severe dry eye; have an active eye infection or active inflammation; have signs of corneal disease characterized by general thinning and cone-shaped protrusion in the center of the cornea (keratoconus) or keratoconus suspect; have abnormal features of the outer part of the eye (cornea) to be implanted; have active abnormal immune response (autoimmune) or connective tissue diseases; do not have enough corneal thickness to safely have the procedure performed; have a recent herpes eye infection or problems resulting from a previous infection; have uncontrolled build-up of high pressure in the eye (glaucoma); have uncontrolled high blood sugar (diabetes).

There are non-surgical alternatives to the Raindrop® Near Vision Inlay, which include reading glasses or contact lenses.

Before having the Raindrop® Near Vision Inlay procedure you should have a complete eye examination and talk with your eye care provider about alternative treatments, potential benefits, complications, risks, healing time, and any other concerns you have about having the procedure.

1. Raindrop® Near Vision Inlay Prescribing Label – ReVision Optics, Inc.

* Intermediate vision was measured in the pivotal clinical study, but it was not an endpoint.

IMPORTANT: For full safety information please click to view our Patient Information Brochure (US), Professional Use Information Brochure (US), Raindrop® Near Vision Inlay Instructions for Use (US), Inlay Inserter Chuck Handle Instructions for Use (US), Raindrop® Near Vision Inlay Instructions for Use (OUS), Inlay Inserter Chuck Handle Instructions for Use (OUS), talk with your doctor, or call Raindrop Customer Support at 1-866-934-6592.

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Date Modified 10/27/17