| Device Type ID | 4328 |
| Device Name | Implant, Eye Valve |
| Regulation Description | Aqueous Shunt. |
| Regulation Medical Specialty | Ophthalmic |
| 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) |
| CFR Regulation Number | 886.3920 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KYF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4328 |
| Device | Implant, Eye Valve |
| Product Code | KYF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Aqueous Shunt. |
| CFR Regulation Number | 886.3920 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALLERGAN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEW WORLD MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Shunt | 289 |
Adverse Event Without Identified Device Or Use Problem | 266 |
Malposition Of Device | 133 |
Complete Blockage | 73 |
Partial Blockage | 28 |
Device Issue | 24 |
Mechanical Jam | 24 |
No Flow | 22 |
Fracture | 22 |
Failure To Deliver | 21 |
Activation, Positioning Or Separation Problem | 20 |
Physical Property Issue | 20 |
Appropriate Term/Code Not Available | 20 |
Insufficient Information | 17 |
Break | 16 |
Migration Or Expulsion Of Device | 16 |
Expiration Date Error | 15 |
Device Markings / Labelling Problem | 14 |
Device Operates Differently Than Expected | 13 |
Migration | 11 |
Obstruction Of Flow | 11 |
Device Dislodged Or Dislocated | 10 |
Occlusion Within Device | 9 |
IOL (Intraocular Lens) Implant | 7 |
Use Of Device Problem | 7 |
No Apparent Adverse Event | 7 |
Retraction Problem | 6 |
Improper Or Incorrect Procedure Or Method | 6 |
Patient-Device Incompatibility | 6 |
Difficult Or Delayed Positioning | 5 |
Inadequate Filtration Process | 5 |
Material Deformation | 4 |
Positioning Failure | 4 |
Off-Label Use | 4 |
Difficult To Position | 4 |
Inaccurate Delivery | 4 |
Deformation Due To Compressive Stress | 4 |
Component Missing | 3 |
Material Twisted / Bent | 3 |
Failure To Prime | 3 |
Material Too Rigid Or Stiff | 3 |
Separation Failure | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Unintended Movement | 2 |
Physical Resistance / Sticking | 2 |
Excess Flow Or Over-Infusion | 2 |
Defective Device | 2 |
Detachment Of Device Or Device Component | 2 |
Filtration Problem | 2 |
Defective Component | 2 |
Extrusion | 2 |
Coiled | 1 |
Output Below Specifications | 1 |
Activation Failure Including Expansion Failures | 1 |
Material Puncture / Hole | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Improper Device Output | 1 |
Material Integrity Problem | 1 |
Corroded | 1 |
Product Quality Problem | 1 |
Device Inoperable | 1 |
Unstable | 1 |
Shutter | 1 |
Torn Material | 1 |
Fluid Leak | 1 |
Material Erosion | 1 |
Kinked | 1 |
Material Rupture | 1 |
Incomplete Or Missing Packaging | 1 |
Leak / Splash | 1 |
Valve(s), Failure Of | 1 |
| Total Device Problems | 1221 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Innovative Ophthalmic Products, Inc | II | Mar-25-2016 |