Definition: An Intraocular Pressure Lowering Implant Is A Device Intended To Reduce Intraocular Pressure When Implanted In Eyes Which Have Not Failed Conventional Medical And Surgical Treatment.
| Device Type ID | 4449 |
| Device Name | Intraocular Pressure Lowering Implant |
| Physical State | This Device Category Includes Various Materials, Both Biodegradable And Non-biodegradable, And Includes Devices Of Various Designs. |
| Technical Method | An Intraocular Pressure Lowering Implant Uses Various Methods Such As Increasing Aqueous Outflow To Reduce Intraocular Pressure |
| Target Area | 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 | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OGO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4449 |
| Device | Intraocular Pressure Lowering Implant |
| Product Code | OGO |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 214 |
Malposition Of Device | 84 |
Obstruction Of Flow | 44 |
Use Of Device Problem | 34 |
Device Dislodged Or Dislocated | 14 |
Insufficient Information | 14 |
Improper Or Incorrect Procedure Or Method | 9 |
Occlusion Within Device | 7 |
No Apparent Adverse Event | 5 |
Difficult To Position | 4 |
Partial Blockage | 2 |
Unsealed Device Packaging | 2 |
Device Handling Problem | 2 |
Invalid Sensing | 2 |
Difficult Or Delayed Positioning | 2 |
Unexpected Therapeutic Results | 2 |
Patient-Device Incompatibility | 2 |
Device Operates Differently Than Expected | 1 |
Material Twisted / Bent | 1 |
Migration Or Expulsion Of Device | 1 |
Contamination During Use | 1 |
Failure To Advance | 1 |
Migration | 1 |
Contamination / Decontamination Problem | 1 |
Stent | 1 |
Material Fragmentation | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Break | 1 |
Positioning Problem | 1 |
Component Falling | 1 |
Entrapment Of Device | 1 |
| Total Device Problems | 458 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alcon Research, LTD. | I | Oct-23-2018 |