| Device Type ID | 4367 |
| Device Name | Lens, Intraocular, Accommodative |
| 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 | NAA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4367 |
| Device | Lens, Intraocular, Accommodative |
| Product Code | NAA |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Intraocular Lens. |
| CFR Regulation Number | 886.3600 [🔎] |
| Device Problems | |
|---|---|
Device Dislodged Or Dislocated | 526 |
Adverse Event Without Identified Device Or Use Problem | 187 |
Break | 15 |
Difficult To Position | 5 |
Insufficient Information | 5 |
Malposition Of Device | 4 |
Positioning Problem | 3 |
Torn Material | 3 |
Material Opacification | 3 |
Mechanical Jam | 2 |
Appropriate Term/Code Not Available | 2 |
Bent | 2 |
Material Twisted / Bent | 2 |
Optical Discoloration | 1 |
Fracture | 1 |
Material Discolored | 1 |
Material Integrity Problem | 1 |
Deformation Due To Compressive Stress | 1 |
Positioning Failure | 1 |
Folded | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Haptic | 1 |
Mechanical Problem | 1 |
Difficult To Advance | 1 |
Mechanics Altered | 1 |
| Total Device Problems | 771 |