| Device |
folders and injectors, intraocular lens (iol) |
| Regulation Description |
Intraocular lens guide. |
| Product Code | MSS |
| Regulation Number |
886.4300
|
|---|
| Device Class |
1
|
| Device Problems |
| No Known Device Problem |
234 |
| Haptic(s), bent |
175 |
| Lens (IOL), torn, split, cracked |
157 |
| Lens Damaged in Delivery System |
129 |
| Other (for use when an appropriate device code cannot be identified) |
122 |
| Plunger Override |
109 |
| Haptic Damaged in Delivery System |
101 |
| Haptic(s), broken |
59 |
| Lens, damaged by cartridge |
43 |
| Failure to deliver |
41 |
| Lens Stuck in Delivery System |
28 |
| Use of Device Issue |
21 |
| Lens, stuck in cartridge |
20 |
| Haptic, Kinked |
19 |
| No Information |
16 |
| No code available |
7 |
| Lens (IOL), scratch, mark on |
7 |
| Delivered as unsterile product |
7 |
| Inaccurate delivery |
6 |
| Split |
6 |
| Bent |
6 |
| Unknown (for use when the device problem is not known) |
6 |
| Lens, difficulty loading into cartridge |
6 |
| Delivery System Issue, No Description |
6 |
| Haptic, Missing |
5 |
| Deployment issue |
5 |
| Tears, rips, holes in device, device material |
5 |
| Particulates |
4 |
| Difficult to insert |
4 |
| Lens, malposition of |
4 |
| Lens replacement |
4 |
| Haptic Stuck in Delivery System |
4 |
| Plunger Issue, No Description |
3 |
| Mechanical jam |
3 |
| Defective component |
3 |
| Folding Issue |
3 |
| Haptic(s), detached |
3 |
| Device Issue |
3 |
| Defective item |
2 |
| Difficult to position |
2 |
| Fitting problem |
2 |
| Detachment of device component |
2 |
| Crack |
2 |
| Difficult to advance |
2 |
| Torn material |
2 |
| Packaging issue |
1 |
| Expulsion |
1 |
| Nozzle Tip Issue, No Description |
1 |
| Explanted |
1 |
| Difficult to fold or unfold |
1 |
| Failure to fold |
1 |
| Foreign material |
1 |
| Injector system failure, no infusion |
1 |
| Lens, opacification of |
1 |
| Lens, vaulting |
1 |
| Mislabeled |
1 |
| Optical decentration |
1 |
| Break |
1 |
| Wedge filter problem |
1 |
| Premature deployment |
1 |
| Device remains implanted |
1 |
| Sharp/jagged/rough/etched/scratched |
1 |
| Lens (IOL), line, crease on |
1 |
| Malfunction |
1 |
| Failure to advance |
1 |
| Total Device Problems |
1418 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
