| Device Type ID | 4325 |
| Device Name | Lens, Guide, Intraocular |
| Regulation Description | Intraocular Lens Guide. |
| 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 | 510(K) Exempt |
| CFR Regulation Number | 886.4300 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KYB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 4325 |
| Device | Lens, Guide, Intraocular |
| Product Code | KYB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Intraocular Lens Guide. |
| CFR Regulation Number | 886.4300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STAAR | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STAAR SURGICAL COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 146 |
Crack | 141 |
Break | 117 |
Positioning Failure | 65 |
Difficult Or Delayed Positioning | 61 |
Material Deformation | 47 |
Appropriate Term/Code Not Available | 45 |
Split | 31 |
Adverse Event Without Identified Device Or Use Problem | 27 |
Bent | 23 |
Device Operates Differently Than Expected | 22 |
Torn Material | 16 |
Delivery System Failure | 12 |
Scratched Material | 12 |
Device Damaged By Another Device | 10 |
Material Fragmentation | 8 |
Stretched | 7 |
Material Integrity Problem | 7 |
Material Split, Cut Or Torn | 7 |
Deformation Due To Compressive Stress | 7 |
Defective Device | 6 |
Premature Activation | 6 |
Material Separation | 6 |
Insufficient Information | 5 |
Failure To Eject | 5 |
Material Frayed | 5 |
Contamination During Use | 5 |
Failure To Advance | 5 |
Material Distortion | 4 |
Hole In Material | 4 |
Material Protrusion / Extrusion | 4 |
Injection System | 4 |
Sticking | 3 |
Dent In Material | 3 |
Device Damaged Prior To Use | 3 |
Device Operational Issue | 3 |
Physical Resistance | 3 |
Contamination / Decontamination Problem | 3 |
IOL (Intraocular Lens) Implant | 3 |
Use Of Device Problem | 3 |
Device Difficult To Setup Or Prepare | 2 |
Flare Or Flash | 2 |
Entrapment Of Device | 2 |
Material Rupture | 2 |
Haptic | 2 |
Physical Resistance / Sticking | 2 |
Mechanical Jam | 2 |
System | 2 |
Device Handling Problem | 1 |
Plunger | 1 |
Material Too Rigid Or Stiff | 1 |
Aspiration Issue | 1 |
Positioning Problem | 1 |
Difficult To Insert | 1 |
Difficult To Advance | 1 |
Separation Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Device Slipped | 1 |
Collapse | 1 |
Inaccurate Delivery | 1 |
Material Discolored | 1 |
Product Quality Problem | 1 |
Material Twisted / Bent | 1 |
Burst Container Or Vessel | 1 |
Fracture | 1 |
Material Puncture / Hole | 1 |
Melted | 1 |
Component Missing | 1 |
Failure To Deliver | 1 |
Obstruction Of Flow | 1 |
Activation, Positioning Or Separation Problem | 1 |
Difficult To Open Or Close | 1 |
Tip | 1 |
| Total Device Problems | 935 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Staar Surgical Co. | II | Jun-14-2016 |