| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
| |
| Device | KAMRA INLAY |
|---|
| Generic Name | Implant, corneal, refractive |
|---|
| Applicant | CorneaGen
1200 6th Avenue
Suite 300
Seattle, WA 98101 |
|---|
| PMA Number | P120023 |
|---|
| Date Received | 12/12/2012 |
|---|
| Decision Date | 04/17/2015 |
|---|
|
Withdrawal Date
|
02/03/2022 |
|---|
| Product Code |
LQE |
| Docket Number | 15M-1326 |
|---|
| Notice Date | 04/29/2015 |
|---|
| Advisory Committee |
Ophthalmic |
|---|
| Clinical Trials | NCT00819299
|
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Recalls | CDRH Recalls |
|---|
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 REFRACTIVECYLINDER, 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. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
Labeling Part 2 |
|---|
| Post-Approval Study | Show Report Schedule and Study Progress |
|---|
| Supplements: |
S001 S002 S004 S005 |
|
|
