| Device Type ID | 4345 |
| Device Name | Vitrectomy, Instrument Cutter |
| Regulation Description | Vitreous Aspiration And Cutting 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) |
| CFR Regulation Number | 886.4150 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MLZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 4345 |
| Device | Vitrectomy, Instrument Cutter |
| Product Code | MLZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vitreous Aspiration And Cutting Instrument. |
| CFR Regulation Number | 886.4150 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALCON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALCON RESEARCH, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Markings / Labelling Problem | 7 |
Failure To Cut | 4 |
Device Operates Differently Than Expected | 3 |
Incorrect Device Or Component Shipped | 3 |
Device Operational Issue | 2 |
Physical Property Issue | 2 |
Flaked | 1 |
| Total Device Problems | 22 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Medical Optics Inc. (AMO) | II | May-16-2017 |