| Device Type ID | 4329 |
| Device Name | Device, Irrigation, Ocular Surgery |
| Regulation Description | Ocular Surgery Irrigation Device. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 886.4360 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KYG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4329 |
| Device | Device, Irrigation, Ocular Surgery |
| Product Code | KYG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ocular Surgery Irrigation Device. |
| CFR Regulation Number | 886.4360 [🔎] |
| Device Problems | |
|---|---|
Knife | 148 |
Dull, Blunt | 116 |
Trocar | 44 |
Device Contamination With Chemical Or Other Material | 38 |
Failure To Cut | 25 |
Fluid Leak | 22 |
Adverse Event Without Identified Device Or Use Problem | 20 |
Fitting Problem | 17 |
Leak / Splash | 13 |
Syringe | 12 |
Valve | 12 |
Device Operates Differently Than Expected | 11 |
Tip | 11 |
Detachment Of Device Component | 8 |
Tube | 6 |
Probe | 6 |
Detachment Of Device Or Device Component | 5 |
Device Dislodged Or Dislocated | 5 |
Particulates | 5 |
Device Operational Issue | 5 |
Bent | 5 |
Component Missing | 4 |
Appropriate Term/Code Not Available | 4 |
Break | 4 |
Device Issue | 4 |
Material Deformation | 4 |
Torn Material | 3 |
Use Of Device Problem | 3 |
Occlusion Within Device | 3 |
Metal Shedding Debris | 2 |
Migration Or Expulsion Of Device | 2 |
Infusion Or Flow Problem | 2 |
Product Quality Problem | 2 |
Defective Component | 2 |
Insufficient Information | 2 |
Material Distortion | 2 |
Scratched Material | 2 |
Hub | 2 |
Kinked | 2 |
Insufficient Flow Or Under Infusion | 1 |
Optical Fiber | 1 |
Inability To Irrigate | 1 |
Positioning Problem | 1 |
Thermometer | 1 |
Partial Blockage | 1 |
Sticking | 1 |
Failure To Infuse | 1 |
Aspiration Issue | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Material Fragmentation | 1 |
Material Separation | 1 |
Physical Resistance | 1 |
Disassembly | 1 |
Unintended Ejection | 1 |
Obstruction Of Flow | 1 |
Inadequate Lighting | 1 |
Connection Problem | 1 |
| Total Device Problems | 601 |