| Device |
lens, guide, intraocular |
| Regulation Description |
Intraocular lens guide. |
| Product Code | KYB |
| Regulation Number |
886.4300
|
|---|
| Device Class |
1
|
| Device Problems |
| Lens (IOL), torn, split, cracked |
238 |
| Lens Damaged in Delivery System |
206 |
| Haptic Damaged in Delivery System |
174 |
| Lens, damaged by cartridge |
139 |
| Other (for use when an appropriate device code cannot be identified) |
104 |
| Haptic(s), bent |
92 |
| No Known Device Problem |
44 |
| Plunger Override |
32 |
| Device or device component damaged by another device |
28 |
| Haptic(s), broken |
28 |
| Lens, stuck in cartridge |
26 |
| Use of Device Issue |
22 |
| No Information |
20 |
| Lens Stuck in Delivery System |
19 |
| Inaccurate delivery |
15 |
| Device remains implanted |
15 |
| Unknown (for use when the device problem is not known) |
13 |
| Haptic, Kinked |
13 |
| Foreign material |
11 |
| No code available |
10 |
| Plunger Issue, No Description |
10 |
| Mechanical jam |
9 |
| Difficult to insert |
7 |
| Haptic Stuck in Delivery System |
6 |
| Crack |
6 |
| Packaging issue |
5 |
| Haptic, Stuck to Optic |
5 |
| Lens, malposition of |
5 |
| Haptic(s), detached |
4 |
| Deployment issue |
4 |
| Break |
4 |
| Split |
4 |
| Haptic Issue, No Description |
3 |
| Physical resistance |
3 |
| Nozzle Tip, Stressed, Split |
3 |
| Difficult to advance |
3 |
| Lens replacement |
3 |
| Device damaged prior to use |
3 |
| Lens (IOL), scratch, mark on |
3 |
| Lens, difficulty loading into cartridge |
3 |
| Foreign material present in device |
2 |
| Haptic, Missing |
2 |
| Misplacement |
2 |
| Tip breakage |
2 |
| Malposition of device |
2 |
| Delivery System Issue, No Description |
2 |
| Device Issue |
2 |
| Dry, failure to |
2 |
| Folding Issue |
2 |
| Defective item |
2 |
| Failure to deliver |
2 |
| Mislabeled |
2 |
| Delivery system failure |
2 |
| Detachment of device or device component |
1 |
| Particulates |
1 |
| Difficult to position |
1 |
| Implant, removal of |
1 |
| Plunger not Aligned Properly |
1 |
| Bent |
1 |
| Tears, rips, holes in device, device material |
1 |
| Optical decentration |
1 |
| Device emits odor |
1 |
| User used incorrect product for intended use |
1 |
| Component(s), worn |
1 |
| Failure to fold |
1 |
| Delivered as unsterile product |
1 |
| Replace |
1 |
| Rupture due to damage from surgical instrument |
1 |
| Fitting problem |
1 |
| Overdelivery |
1 |
| Lens, repositioning of |
1 |
| Total Device Problems |
1386 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
