| Device Type ID | 4342 |
| Device Name | Lens, Multifocal Intraocular |
| 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 | MFK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4342 |
| Device | Lens, Multifocal Intraocular |
| Product Code | MFK |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Intraocular Lens. |
| CFR Regulation Number | 886.3600 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 914 |
Nonstandard Device | 79 |
Inadequacy Of Device Shape And/or Size | 69 |
Device Operates Differently Than Expected | 62 |
Appropriate Term/Code Not Available | 54 |
Insufficient Information | 50 |
Unintended Movement | 39 |
Scratched Material | 34 |
IOL (Intraocular Lens) Implant | 32 |
Device Contamination With Chemical Or Other Material | 21 |
Break | 19 |
Torn Material | 19 |
Device Dislodged Or Dislocated | 18 |
Migration Or Expulsion Of Device | 17 |
Material Opacification | 9 |
Crack | 8 |
Malposition Of Device | 7 |
Difficult Or Delayed Positioning | 7 |
Bent | 6 |
Patient-Device Incompatibility | 6 |
Failure To Unfold Or Unwrap | 6 |
Positioning Problem | 5 |
Haptic | 4 |
Detachment Of Device Component | 4 |
Product Quality Problem | 4 |
Invalid Sensing | 4 |
Use Of Device Problem | 3 |
Incorrect Measurement | 3 |
Optical Decentration | 3 |
Difficult To Fold Or Unfold | 3 |
Sticking | 3 |
Material Deformation | 2 |
Device Damaged By Another Device | 2 |
Positioning Failure | 2 |
Device Handling Problem | 2 |
Material Distortion | 2 |
Difficult To Insert | 2 |
Kinked | 2 |
Separation Problem | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Material Puncture / Hole | 2 |
Suction Problem | 2 |
Material Split, Cut Or Torn | 2 |
Device Tipped Over | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Degraded | 1 |
Contamination / Decontamination Problem | 1 |
Delivered As Unsterile Product | 1 |
Defective Component | 1 |
Flare Or Flash | 1 |
Improper Device Output | 1 |
Unexpected Therapeutic Results | 1 |
Unstable | 1 |
Valve | 1 |
Human-Device Interface Problem | 1 |
Material Twisted / Bent | 1 |
Fracture | 1 |
Wrinkled | 1 |
Delivery System Failure | 1 |
Mechanical Problem | 1 |
Difficult To Position | 1 |
Material Rupture | 1 |
Device Damaged Prior To Use | 1 |
Air Leak | 1 |
Expulsion | 1 |
| Total Device Problems | 1558 |