Device |
artificial iris |
Definition |
Artificial iris is intended to be implanted to replace the natural iris of the eye. |
Physical State |
An artificial iris is manufactured from a polymeric material and may contain color additives to mimic the appearance of the natural iris. |
Technical Method |
The artificial iris reduces the light sensitivity and/or glare associated with aniridia through the artificial pupil at the center of the prosthesis. The Artificial iris does not include optical power for the correction of refractive errors. |
Target Area |
Eye |
Review Panel |
Ophthalmic |
Product Code | QBT |
Premarket Review |
Ophthalmic Devices
(DHT1A)
Ophthalmic Devices
(DHT1A)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |