Device |
phakic toric intraocular lens |
Regulation Description |
Intraocular lens. |
Definition |
Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens. |
Physical State |
The device has a similar appearance and construction to any other intraocular lens. An intraocular lens is a device made of materials such as glass or plastic. |
Technical Method |
The device is implanted into the eye without removing the natural crystalline lens. It is used to correct refractive errors, specifically astigmatism (with or without myopia or hyperopia). |
Target Area |
The device is implanted within the eye without removing the eye's natural crystalline lens. It can be placed just in front of or just behind the iris. |
Regulation Medical Specialty |
Ophthalmic |
Review Panel |
Ophthalmic |
Product Code | QCB |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
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 |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Third Party Review |
Not Third Party Eligible |