| Device Type ID | 4343 |
| Device Name | Lens, Intraocular, Toric Optics |
| Regulation Description | Intraocular Lens. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Intraocular And Corneal Implants Devices Branch (ICIB) |
| Submission Type | PMA |
| CFR Regulation Number | 886.3600 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MJP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4343 |
| Device | Lens, Intraocular, Toric Optics |
| Product Code | MJP |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Intraocular Lens. |
| CFR Regulation Number | 886.3600 [🔎] |
| Device Problems | |
|---|---|
Device Dislodged Or Dislocated | 169 |
Adverse Event Without Identified Device Or Use Problem | 75 |
Insufficient Information | 64 |
Device Operates Differently Than Expected | 27 |
Break | 12 |
Nonstandard Device | 10 |
Positioning Problem | 9 |
Malposition Of Device | 7 |
Appropriate Term/Code Not Available | 6 |
Torn Material | 5 |
Mechanical Problem | 4 |
Device Markings / Labelling Problem | 4 |
Patient-Device Incompatibility | 4 |
Packaging Problem | 3 |
Leak / Splash | 3 |
Haptic | 3 |
Inadequacy Of Device Shape And/or Size | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Scratched Material | 2 |
Material Rupture | 2 |
Unexpected Therapeutic Results | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Material Integrity Problem | 2 |
Activation, Positioning Or Separation Problem | 2 |
Overcorrection | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Lenses | 1 |
Degraded | 1 |
Component Missing | 1 |
Device Inoperable | 1 |
Unstable | 1 |
Collapse | 1 |
Unintended Movement | 1 |
Difficult To Fold Or Unfold | 1 |
Material Opacification | 1 |
Off-Label Use | 1 |
Component Or Accessory Incompatibility | 1 |
Protective Measures Problem | 1 |
| Total Device Problems | 435 |