| Device Type ID | 4238 |
| Device Name | Forceps, 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 | HNR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4238 |
| Device | Forceps, Ophthalmic |
| Product Code | HNR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Ophthalmic Surgical Instrument. |
| CFR Regulation Number | 886.4350 [🔎] |
| Device Problems | |
|---|---|
Break | 21 |
Material Fragmentation | 12 |
Particulates | 6 |
Device Dislodged Or Dislocated | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Device Handling Problem | 3 |
Defective Device | 3 |
Material Separation | 2 |
Mechanical Jam | 1 |
Detachment Of Device Component | 1 |
Mechanical Problem | 1 |
Mechanics Altered | 1 |
Cannula | 1 |
Inadequate Service | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Metal Shedding Debris | 1 |
Misconnection | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 64 |