| Device Type ID | 4434 |
| Device Name | Implant, Corneal, Refractive |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Contact Lenses And Retinal Devices Branch (CLRD) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LQE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4434 |
| Device | Implant, Corneal, Refractive |
| Product Code | LQE |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 146 |
Device Dislodged Or Dislocated | 68 |
No Apparent Adverse Event | 12 |
Improper Or Incorrect Procedure Or Method | 6 |
Contamination During Use | 5 |
Labelling, Instructions For Use Or Training Problem | 5 |
Malposition Of Device | 4 |
Biological Environmental Factor | 4 |
Insufficient Information | 3 |
Wrinkled | 3 |
Use Of Device Problem | 3 |
Positioning Problem | 2 |
Device Contamination With Chemical Or Other Material | 1 |
Material Fragmentation | 1 |
Material Opacification | 1 |
Environmental Particulates | 1 |
Material Disintegration | 1 |
| Total Device Problems | 266 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | AcuFocus, Inc. | II | Mar-24-2016 |
| 2 | RVO 2.0, INC | I | Mar-05-2019 |
| 3 | Revision Optics Inc | II | Mar-21-2017 |