Definition: Lacrimal Stents And Intubations Sets Are Intended To Repair The Lacrimal Drainage System. Lacrimal Stents And Intubations Sets Are Indicated For, But Limited To, The Treatment Of Epiphora In Infants And Adults; Canalicular Pathologies Such As Stenosi
| Device Type ID | 4450 |
| Device Name | Lacrimal Stents And Intubation Sets |
| Physical State | A Stent Is A Small Tube Generally Made Of Silicone That Is Placed At The Point Of Constriction To Open It Up. The Intubation Set Is Composed Of A Balloon And Catheter Composed Of Silicone. |
| Technical Method | The Nasal Punctum Is Probed With A Fine Stainless Steel Probe To Determine The Patency Of The Opening And Adjoining Lacrimal Duct. This Procedure Is Known As Dilation And Then Maybe Followed By Sterile Saline Irrigation To Test For Lower Patency Of T |
| Target Area | These Devices Are Restricted To The Nasal Punctum And Lacrimal Ducts Of The Eye. |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Intraocular And Corneal Implants Devices Branch (ICIB) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | OKS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4450 |
| Device | Lacrimal Stents And Intubation Sets |
| Product Code | OKS |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANODYNE | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
ARMADILLO BIOMEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KANEKA CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LJT SURGICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Handling Problem | 25 |
Use Of Device Problem | 25 |
Material Separation | 18 |
Material Puncture / Hole | 10 |
Material Deformation | 5 |
Material Split, Cut Or Torn | 2 |
Balloon | 2 |
Catheter | 1 |
Defective Component | 1 |
Burst Container Or Vessel | 1 |
Inflation Problem | 1 |
Device Operates Differently Than Expected | 1 |
Leak / Splash | 1 |
Decrease In Pressure | 1 |
Material Rupture | 1 |
Break | 1 |
Cut In Material | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 98 |