| Device Type ID | 4443 |
| Device Name | Lens, Intraocular, Phakic |
| 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 |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MTA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4443 |
| Device | Lens, Intraocular, Phakic |
| Product Code | MTA |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Inadequacy Of Device Shape And/or Size | 3828 |
Appropriate Term/Code Not Available | 1484 |
Device Operates Differently Than Expected | 1104 |
Device Dislodged Or Dislocated | 326 |
Adverse Event Without Identified Device Or Use Problem | 247 |
Torn Material | 169 |
Unintended Movement | 136 |
Misfocusing | 131 |
No Apparent Adverse Event | 123 |
Insufficient Information | 105 |
Break | 52 |
Positioning Failure | 51 |
Optical Problem | 33 |
Device Contamination With Chemical Or Other Material | 22 |
Improper Or Incorrect Procedure Or Method | 21 |
Patient-Device Incompatibility | 18 |
Off-Label Use | 17 |
Activation Failure Including Expansion Failures | 13 |
Difficult To Fold Or Unfold | 12 |
Use Of Device Problem | 8 |
Positioning Problem | 7 |
Scratched Material | 7 |
Entrapment Of Device | 6 |
Failure To Unfold Or Unwrap | 6 |
Device Markings / Labelling Problem | 5 |
Missing Value Reason | 4 |
Defective Device | 4 |
Fracture | 4 |
Optical Decentration | 3 |
Activation, Positioning Or Separation Problem | 3 |
Crack | 3 |
Difficult To Position | 3 |
Sticking | 3 |
Mechanical Jam | 3 |
Device Handling Problem | 2 |
Incomplete Or Missing Packaging | 2 |
Shelf Life Exceeded | 2 |
Difficult To Insert | 2 |
Malposition Of Device | 2 |
Difficult Or Delayed Positioning | 2 |
Contamination / Decontamination Problem | 2 |
Bent | 2 |
Contamination During Use | 2 |
Material Discolored | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Material Twisted / Bent | 1 |
Migration Or Expulsion Of Device | 1 |
Difficult To Remove | 1 |
Delivered As Unsterile Product | 1 |
Difficult To Open Or Close | 1 |
Difficult To Advance | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Device Slipped | 1 |
Cut In Material | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Device Issue | 1 |
Folded | 1 |
Device Damaged By Another Device | 1 |
Material Opacification | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Material Deformation | 1 |
| Total Device Problems | 7997 |