| Device Type ID | 4218 |
| Device Name | Cannula, Ophthalmic |
| Regulation Description | Manual Ophthalmic Surgical Instrument. |
| 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 | 886.4350 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HMX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4218 |
| Device | Cannula, Ophthalmic |
| Product Code | HMX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Ophthalmic Surgical Instrument. |
| CFR Regulation Number | 886.4350 [🔎] |
| Device Problems | |
|---|---|
Break | 9 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Migration Or Expulsion Of Device | 5 |
Material Separation | 4 |
Detachment Of Device Component | 3 |
Cannula | 3 |
Maintenance Does Not Comply To Manufacturers Recommendations | 3 |
Cannula, Inner | 2 |
Fracture | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Material Fragmentation | 2 |
Device Handling Problem | 2 |
Expulsion | 1 |
Material Deformation | 1 |
Unintended Collision | 1 |
Dent In Material | 1 |
Mechanical Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Insufficient Information | 1 |
Restricted Flow Rate | 1 |
Scratched Material | 1 |
Device Operates Differently Than Expected | 1 |
Infusion Or Flow Problem | 1 |
Material Integrity Problem | 1 |
Difficult To Flush | 1 |
Physical Property Issue | 1 |
| Total Device Problems | 60 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beaver Visitec | II | Mar-27-2019 |
| 2 | Beaver-Visitec International Inc. | II | May-27-2014 |
| 3 | Ellex IScience, Inc. | II | Oct-01-2018 |
| 4 | Ellex IScience, Inc. | II | Sep-04-2014 |
| 5 | Hill-Rom, Inc. | II | Jun-19-2015 |