Device |
ophthalmic sealant |
Definition |
An ophthalmic sealant is intended to maintain an incision closure and aid in preventing fluid egress from incisions in the eye. |
Physical State |
A topical liquid/hydrogel/material which creates a temporary adherent closure. |
Technical Method |
An ophthalmic sealant device is applied to an incision in the eye following an intraocular surgery. Once applied to the surface of the eye, the device adheres to the ocular tissue and aids in incision closure and prevention of fluid egress. |
Target Area |
eye |
Review Panel |
Ophthalmic |
Product Code | PFZ |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|