| Device |
intraocular lens |
| Regulation Description |
Intraocular lens. |
| Product Code | HQL |
| Regulation Number |
886.3600
|
|---|
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
|
51
|
45
|
32
|
43
|
33
|
38
|
11
|
|
| Device Problems |
| Lens (IOL), torn, split, cracked |
2330 |
| No Known Device Problem |
2151 |
| Haptic(s), bent |
1214 |
| Device remains implanted |
1111 |
| Haptic(s), broken |
1044 |
| Other (for use when an appropriate device code cannot be identified) |
819 |
| No Information |
766 |
| Explanted |
680 |
| Haptic Damaged in Delivery System |
650 |
| Lens replacement |
539 |
| No code available |
437 |
| Lens Damaged in Delivery System |
412 |
| Lens Stuck in Delivery System |
405 |
| Malposition of device |
366 |
| Use of Device Issue |
309 |
| Lens, vaulting |
303 |
| Unknown (for use when the device problem is not known) |
245 |
| Failure to deliver |
202 |
| Material opacification |
169 |
| Break |
151 |
| Lens, stuck in cartridge |
147 |
| Lens (IOL), scratch, mark on |
101 |
| Bent |
100 |
| Haptic, Kinked |
91 |
| Lens (IOL), dislocated intraocular |
89 |
| Scratched material |
81 |
| Inaccurate delivery |
81 |
| Plunger Override |
80 |
| Haptic(s), detached |
79 |
| Haptic Stuck in Delivery System |
75 |
| Dislodged or dislocated |
69 |
| Defective item |
67 |
| Lens, malposition of |
65 |
| Lens, opacification of |
64 |
| Optical decentration |
60 |
| Lens Issue, No Description |
56 |
| Lens, repositioning of |
50 |
| Lens, cloudy |
49 |
| Foreign material |
49 |
| Lens, deposits on |
48 |
| Implant, removal of |
47 |
| Sticking |
47 |
| Device Issue |
40 |
| Foreign material present in device |
38 |
| Torn material |
37 |
| Failure to fold |
37 |
| Haptic, Stuck to Optic |
34 |
| Crack |
34 |
| Dissatisfaction |
34 |
| Haptic Issue, No Description |
33 |
| Lens, damaged by cartridge |
31 |
| Haptic, Missing |
28 |
| Device or device component damaged by another device |
24 |
| Detachment of device component |
22 |
| Difficult to position |
22 |
| Material discolored |
21 |
| Difficult to fold or unfold |
18 |
| Lens, difficulty loading into cartridge |
18 |
| Lens (IOL), defective, problem not specified |
16 |
| Positioning Issue |
16 |
| Difficult to insert |
16 |
| Haptic(s), fractured |
15 |
| Deployment issue |
15 |
| Implant, repositioning of |
15 |
| Fitting problem |
15 |
| Tears, rips, holes in device, device material |
15 |
| Power calculation error due to software problem |
12 |
| Component missing |
11 |
| Lens (IOL), line, crease on |
11 |
| Calcified |
10 |
| Lens, discoloration of |
10 |
| Device operates differently than expected |
10 |
| Bubble(s) |
10 |
| Failure to unfold or unwrap |
10 |
| Unfold, difficult to |
10 |
| Folding Issue |
9 |
| Mechanical jam |
9 |
| Incorrect measurement |
8 |
| Material twisted |
7 |
| Lens (IOL), nicked, chipped |
7 |
| Defective component |
7 |
| Haptic(s), dislocated |
6 |
| Physical resistance |
6 |
| Dislocated |
6 |
| Lens implant |
6 |
| Kinked |
6 |
| Device damaged prior to use |
5 |
| Particulates |
5 |
| Packaging issue |
5 |
| Material rigid or stiff |
5 |
| Undercorrection |
5 |
| Delivery System Issue, No Description |
4 |
| Wrinkled |
4 |
| User used incorrect product for intended use |
4 |
| Failure to advance |
4 |
| Lens (IOL), migration of intraocular |
4 |
| Split |
3 |
| Lens, Stuck to Itself |
3 |
| Sharp/jagged/rough/etched/scratched |
3 |
| Size incorrect for patient |
3 |
| Total Device Problems |
16720 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
1 |
2 |
3 |
0 |
1 |
| Class III |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
|
|
|
