Definition: Intended To Be Implanted To Replace The Natural Lens Of An Eye.
| Device Type ID | 4409 |
| Device Name | Extended Depth Of Focus Intraocular Lens |
| Physical State | An EDF IOL Has A Similar Appearance And Construction To Any Intraocular Lens. An Intraocular Lens Is A Device Made Of Materials Such As Glass Or Plastic. |
| Technical Method | An Extended Depth Of Focus Intraocular Lens Is One That Uses An Optical Design (e.g., Through Aspheric Shape, Use Of More Than One Refractive Zone, Or Diffractive Technology) That Provides A Continuous Range Of Relatively Clear Vision, Beyond That Ac |
| Target Area | Like All IOLs, An EDF IOL Is Implanted Within The Eye, Either Within Or Outside Of The Capsular Bag, In The Posterior Or Anterior Chamber. |
| 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 | POE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4409 |
| Device | Extended Depth Of Focus Intraocular Lens |
| Product Code | POE |
| 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 | 1289 |
Inadequacy Of Device Shape And/or Size | 177 |
Unintended Movement | 99 |
Appropriate Term/Code Not Available | 67 |
Scratched Material | 38 |
Device Contamination With Chemical Or Other Material | 28 |
Migration Or Expulsion Of Device | 19 |
Device Dislodged Or Dislocated | 18 |
Break | 16 |
Crack | 12 |
Torn Material | 10 |
Invalid Sensing | 9 |
Contamination / Decontamination Problem | 8 |
Mechanical Problem | 6 |
Incorrect Measurement | 5 |
Material Split, Cut Or Torn | 4 |
Difficult Or Delayed Positioning | 4 |
Dent In Material | 4 |
Material Opacification | 3 |
Expulsion | 3 |
Difficult To Insert | 3 |
Device Markings / Labelling Problem | 3 |
Unexpected Therapeutic Results | 3 |
Material Integrity Problem | 2 |
Product Quality Problem | 2 |
Patient-Device Incompatibility | 2 |
Device Operates Differently Than Expected | 2 |
Kinked | 2 |
Malposition Of Device | 2 |
Premature Activation | 2 |
Failure To Unfold Or Unwrap | 2 |
Detachment Of Device Or Device Component | 2 |
Defective Device | 1 |
Device Damaged Prior To Use | 1 |
Positioning Problem | 1 |
Device Handling Problem | 1 |
Patient Device Interaction Problem | 1 |
Inaccurate Information | 1 |
Unsealed Device Packaging | 1 |
Off-Label Use | 1 |
Positioning Failure | 1 |
Hole In Material | 1 |
Arcing | 1 |
Material Deformation | 1 |
Physical Resistance / Sticking | 1 |
Difficult To Fold Or Unfold | 1 |
Material Twisted / Bent | 1 |
Physical Resistance | 1 |
Wrinkled | 1 |
Optical Decentration | 1 |
Contamination During Use | 1 |
Failure To Fold | 1 |
Component Missing | 1 |
| Total Device Problems | 1867 |