|Trade Name||KAMRA INLAY|
|Classification Name||implant, corneal, refractive|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the kamra inlay. 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 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.