| Device |
lens, intraocular, toric optics |
| Regulation Description |
Intraocular lens. |
| Product Code | MJP |
| Regulation Number |
886.3600
|
|---|
| Device Class |
3
|
| Device Problems |
| Device remains implanted |
259 |
| No Information |
81 |
| Lens, malposition of |
39 |
| Lens (IOL), scratch, mark on |
37 |
| Lens replacement |
26 |
| Lens (IOL), torn, split, cracked |
21 |
| Malposition of device |
16 |
| Lens Issue, No Description |
15 |
| Foreign material |
15 |
| Use of Device Issue |
8 |
| Lens (IOL), dislocated intraocular |
8 |
| Difficult to fold or unfold |
7 |
| Failure to fold |
5 |
| No Known Device Problem |
5 |
| Scratched material |
4 |
| Dissatisfaction |
3 |
| Defective item |
3 |
| Optical decentration |
3 |
| Haptic(s), broken |
3 |
| Foreign material present in device |
3 |
| No code available |
2 |
| Sticking |
2 |
| Break |
2 |
| Crack |
2 |
| Lens, deposits on |
2 |
| Defective component |
2 |
| Unknown (for use when the device problem is not known) |
2 |
| Torn material |
2 |
| Folding Issue |
2 |
| Haptic, Stuck to Optic |
1 |
| Device operates differently than expected |
1 |
| Dislodged or dislocated |
1 |
| Unintended movement |
1 |
| Device damaged prior to use |
1 |
| Unfold, difficult to |
1 |
| Difficult to position |
1 |
| Power calculation error due to software problem |
1 |
| User used incorrect product for intended use |
1 |
| Lens, cloudy |
1 |
| Other (for use when an appropriate device code cannot be identified) |
1 |
| Total Device Problems |
590 |
|
|
|
