| Device |
daily wear soft contact lens to reduce the progression of myopia |
| Definition |
Intended to be worn on the surface of the eye in children who have myopia to: • Reduce the rate of progression of myopia, and • Optically correct myopic refractive error. |
| Physical State |
A daily wear soft contact lens to reduce the progression of myopia has a similar appearance and construction to any soft contact lens. It is a device made of a polymer. |
| Technical Method |
A daily wear soft contact lens to reduce the progression of myopia is one that uses an optical design in which part of the optical zone focuses light from distant objects on the retina, and other parts of the optical zone focus light in front of the retina. This is believed to provide a stimulus to slow the axial growth of the eye and to slow the progression of myopia. |
| Target Area |
Like all soft contact lenses, the lens sits on the cornea and surrounding bulbar conjunctiva. |
| Review Panel |
Ophthalmic |
|---|
| Product Code | QIT |
|---|
| 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? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
