KAMRA INLAY

FDA premarket approval P120023 · decided 2015-04-17

Approval details

PMA number

P120023

Trade name

KAMRA INLAY

Generic name

Implant, corneal, refractive

Applicant

Corneagen

Date received

2012-12-12

Decision date

2015-04-17

Days to decision

856 days

Decision code

APWD

Product code

LQE

Advisory committee

Ophthalmic

Expedited review

No

Location

Seattle, WA

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 REFRACTIVECYLINDER, WHO DO NOT REQUIRE GLASSES OR CONTACT LENSES FOR CLEAR DISTANCE VISION, AND WHO REQUIRE NEAR CORRECTION OF +1.00 D TO +2.