| Device |
lens, intraocular, phakic |
| Product Code | MTA |
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
|
0
|
7
|
3
|
5
|
4
|
2
|
0
|
|
| Device Problems |
| Explanted |
1063 |
| Lens, vaulting |
942 |
| Device remains implanted |
239 |
| Other (for use when an appropriate device code cannot be identified) |
215 |
| Unknown (for use when the device problem is not known) |
122 |
| Lens (IOL), torn, split, cracked |
110 |
| Tears, rips, holes in device, device material |
47 |
| Haptic(s), broken |
15 |
| Optical decentration |
11 |
| Lens Damaged in Delivery System |
11 |
| Lens Stuck in Delivery System |
9 |
| Foreign material |
8 |
| Lens, repositioning of |
8 |
| Defective item |
8 |
| Lens, stuck in cartridge |
8 |
| Haptic Damaged in Delivery System |
6 |
| Lens (IOL), scratch, mark on |
5 |
| Lens (IOL), defective, problem not specified |
5 |
| Dislocated |
5 |
| Haptic(s), fractured |
4 |
| Lens, deposits on |
3 |
| Unfold, difficult to |
3 |
| Lens (IOL), dislocated intraocular |
3 |
| Haptic(s), bent |
2 |
| Difficult to remove |
2 |
| Lens (IOL), line, crease on |
2 |
| Plunger Override |
2 |
| Implant, removal of |
1 |
| Particulates |
1 |
| Difficult to position |
1 |
| Lens Issue, No Description |
1 |
| Size incorrect for patient |
1 |
| Undercorrection |
1 |
| Lens, cloudy |
1 |
| Malposition of device |
1 |
| Emergency table stop failure |
1 |
| Lens, opacification of |
1 |
| Total Device Problems |
2868 |
|
|
|
