| Device Type ID | 4341 |
| Device Name | Aid, Surgical, Viscoelastic |
| Regulation Description | Intraocular Fluid. |
| 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 | 886.4275 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LZP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4341 |
| Device | Aid, Surgical, Viscoelastic |
| Product Code | LZP |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Intraocular Fluid. |
| CFR Regulation Number | 886.4275 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 152 |
Device Contamination With Chemical Or Other Material | 114 |
Detachment Of Device Component | 16 |
Leak / Splash | 16 |
Disconnection | 16 |
Syringe | 14 |
Appropriate Term/Code Not Available | 9 |
Contamination / Decontamination Problem | 8 |
Detachment Of Device Or Device Component | 7 |
Insufficient Information | 6 |
Device Markings / Labelling Problem | 5 |
Contamination During Use | 5 |
Device Handling Problem | 4 |
Break | 3 |
Use Of Device Problem | 3 |
Particulates | 2 |
Delivered As Unsterile Product | 2 |
Difficult To Remove | 2 |
Device Operates Differently Than Expected | 2 |
Contamination Of Device Ingredient Or Reagent | 2 |
Cutoff Point | 1 |
Trocar | 1 |
Device Emits Odor | 1 |
Material Opacification | 1 |
Device Packaging Compromised | 1 |
Device Expiration Issue | 1 |
Fluid Leak | 1 |
Shelf Life Exceeded | 1 |
Separation Problem | 1 |
Packaging Problem | 1 |
Fungus In Device Environment | 1 |
Connector | 1 |
Hub | 1 |
Component Falling | 1 |
Burst Container Or Vessel | 1 |
Patient-Device Incompatibility | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Television Unit | 1 |
Connection Problem | 1 |
Cannula | 1 |
Component Missing | 1 |
| Total Device Problems | 409 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Medical Optics Inc (AMO) | II | Dec-12-2014 |
| 2 | Abbott Medical Optics Inc. (AMO) | II | May-10-2017 |