| Device |
extended depth of focus intraocular lens |
| Regulation Description |
Intraocular lens. |
| Definition |
Intended to be implanted to replace the natural lens of an eye. |
| Physical State |
An EDF IOL has a similar appearance and construction to any intraocular lens. An intraocular lens is a device made of materials such as glass or plastic. |
| Technical Method |
An Extended Depth of Focus Intraocular lens is one that uses an optical design (e.g., through aspheric shape, use of more than one refractive zone, or diffractive technology) that provides a continuous range of relatively clear vision, beyond that achievable with the optics of a monofocal lens. Extended Depth of Focus Intraocular lenses may have one or more focal points with any additional focal points or any significant light energy (on the optical axis) restricted to within 1.5 diopters (at the corneal plane) of the focal point associated with the labeled power when tested with a 3mm aperture. |
| Target Area |
Like all IOLs, an EDF IOL is implanted within the eye, either within or outside of the capsular bag, in the posterior or anterior chamber. |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | POE |
|---|
| Premarket Review |
Ophthalmic Devices
(DHT1A)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
PMA
|
|---|
| Regulation Number |
886.3600
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
