| Device Type ID | 4294 |
| Device Name | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| 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 | HQE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 4294 |
| Device | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Product Code | HQE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vitreous Aspiration And Cutting Instrument. |
| CFR Regulation Number | 886.4150 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
A.R.C. LASER GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALCON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALCON RESEARCH, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operational Issue | 73 |
Device Operates Differently Than Expected | 16 |
Material Separation | 10 |
Device Contamination With Chemical Or Other Material | 9 |
Physical Property Issue | 5 |
Particulates | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Appropriate Term/Code Not Available | 3 |
Obstruction Of Flow | 2 |
Failure To Cut | 2 |
Infusion Or Flow Problem | 2 |
Probe | 2 |
Insufficient Information | 2 |
Break | 1 |
Difficult To Insert | 1 |
Material Deformation | 1 |
Partial Blockage | 1 |
Detachment Of Device Component | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Device Issue | 1 |
Material Fragmentation | 1 |
Material Integrity Problem | 1 |
No Flow | 1 |
Connection Problem | 1 |
| Total Device Problems | 145 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bausch & Lomb Inc | II | Sep-27-2018 |
| 2 | Synergetics Inc | II | Oct-18-2016 |