| Device |
lens,intraocular,accommodative |
| Regulation Description |
Intraocular lens. |
| Product Code | NAA |
| Regulation Number |
886.3600
|
|---|
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
|
6
|
4
|
3
|
1
|
4
|
0
|
0
|
|
| Device Problems |
| No Known Device Problem |
127 |
| Malposition of device |
111 |
| Dislodged or dislocated |
49 |
| Break |
24 |
| No Information |
18 |
| Torn material |
14 |
| Device or device component damaged by another device |
9 |
| Bent |
8 |
| Device remains implanted |
8 |
| Positioning Issue |
8 |
| No code available |
7 |
| Lens, vaulting |
7 |
| Optical decentration |
5 |
| Lens replacement |
5 |
| Lens, repositioning of |
4 |
| Use of Device Issue |
4 |
| Implant, removal of |
3 |
| Deployment issue |
3 |
| Lens Issue, No Description |
2 |
| Haptic Damaged in Delivery System |
2 |
| Plunger Override |
2 |
| Size incorrect for patient |
2 |
| Haptic(s), broken |
2 |
| Explanted |
2 |
| Difficult to fold or unfold |
2 |
| Scratched material |
2 |
| Haptic(s), bent |
1 |
| Difficult to insert |
1 |
| Lens, discoloration of |
1 |
| Lens, opacification of |
1 |
| Material rupture |
1 |
| Material separation |
1 |
| Material opacification |
1 |
| Device operates differently than expected |
1 |
| Difficult to advance |
1 |
| Material twisted |
1 |
| Defective item |
1 |
| Other (for use when an appropriate device code cannot be identified) |
1 |
| Device damaged prior to use |
1 |
| Suspect EMI |
1 |
| Lens (IOL), line, crease on |
1 |
| Lens (IOL), scratch, mark on |
1 |
| Total Device Problems |
446 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
