| Device Type ID | 4234 |
| Device Name | Knife, 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 | HNN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4234 |
| Device | Knife, Ophthalmic |
| Product Code | HNN |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Ophthalmic Surgical Instrument. |
| CFR Regulation Number | 886.4350 [🔎] |
| Device Problems | |
|---|---|
Knife | 310 |
Dull, Blunt | 281 |
Failure To Cut | 80 |
Device Operates Differently Than Expected | 18 |
Tip | 10 |
Particulates | 8 |
Bent | 8 |
Product Quality Problem | 6 |
Material Deformation | 6 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Mechanical Problem | 4 |
Device Contamination With Chemical Or Other Material | 3 |
Device Misassembled During Manufacturing / Shipping | 2 |
Break | 2 |
Difficult To Insert | 2 |
Scratched Material | 2 |
Switch, Push Button | 2 |
Appropriate Term/Code Not Available | 2 |
Device Difficult To Setup Or Prepare | 1 |
Physical Property Issue | 1 |
Misassembled | 1 |
Incorrect Software Programming Calculations | 1 |
Physical Resistance | 1 |
Device Damaged Prior To Use | 1 |
Mechanics Altered | 1 |
Nonstandard Device | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 760 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bausch & Lomb Inc Irb | II | Mar-05-2018 |
| 2 | Beaver Visitec | II | Aug-09-2018 |