| Device Type ID | 4355 |
| Device Name | Folders And Injectors, Intraocular Lens (iol) |
| 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) |
| CFR Regulation Number | 886.4300 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MSS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 4355 |
| Device | Folders And Injectors, Intraocular Lens (iol) |
| Product Code | MSS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Intraocular Lens Guide. |
| CFR Regulation Number | 886.4300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT MEDICAL OPTICS INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AST PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BAUSCH & LOMB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BAUSCH & LOMB, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
RAYNER | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
RAYNER & KEELER LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STAAR | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STAAR SURGICAL COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 351 |
Torn Material | 22 |
Break | 9 |
Device Operates Differently Than Expected | 8 |
Mechanical Jam | 7 |
Detachment Of Device Component | 6 |
Split | 6 |
Activation, Positioning Or Separation Problem | 6 |
Bent | 5 |
Difficult To Insert | 5 |
Device Contamination With Chemical Or Other Material | 4 |
Device Handling Problem | 4 |
Haptic | 3 |
Difficult To Advance | 3 |
Loose Or Intermittent Connection | 2 |
Delivery System Failure | 2 |
Mechanical Problem | 2 |
Use Of Device Problem | 2 |
Component Missing | 1 |
Delamination | 1 |
Particulates | 1 |
Tip | 1 |
Appropriate Term/Code Not Available | 1 |
Material Split, Cut Or Torn | 1 |
Difficult Or Delayed Positioning | 1 |
Wrinkled | 1 |
Device Operational Issue | 1 |
Failure To Advance | 1 |
Device Slipped | 1 |
Crack | 1 |
Detachment Of Device Or Device Component | 1 |
Defective Device | 1 |
Insufficient Information | 1 |
Material Rupture | 1 |
Device Damaged Prior To Use | 1 |
Malposition Of Device | 1 |
Scratched Material | 1 |
Kinked | 1 |
Component Falling | 1 |
Sticking | 1 |
Positioning Failure | 1 |
Material Opacification | 1 |
Material Too Rigid Or Stiff | 1 |
Device Issue | 1 |
Device Damaged By Another Device | 1 |
Material Protrusion / Extrusion | 1 |
| Total Device Problems | 475 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aaren Scientific Inc. | II | Nov-08-2017 |
| 2 | Alcon Research, Ltd. | II | Jan-09-2017 |
| 3 | Bausch & Lomb Surgical, Inc. | II | May-16-2017 |