Definition: The Trocar/cannula Set Is A Manual Surgical Instrument Intended For Use As Single-use, Disposable Cannula System For Establishing An Entry Site Conduit For Passing Ophthalmic Instruments Used To Perform Posterior Ophthalmic Surgical Procedures.
| Device Type ID | 4376 |
| Device Name | Cannula, Trocar, 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 | NGY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4376 |
| Device | Cannula, Trocar, Ophthalmic |
| Product Code | NGY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Ophthalmic Surgical Instrument. |
| CFR Regulation Number | 886.4350 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 12 |
Trocar | 9 |
Valve | 6 |
Device Operational Issue | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Cannula | 2 |
Device Operates Differently Than Expected | 1 |
Detachment Of Device Component | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Break | 1 |
Fluid Leak | 1 |
| Total Device Problems | 39 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alcon Research, Ltd. | II | May-18-2016 |