| Device Type ID | 5673 |
| Device Name | Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
| Regulation Description | Surgical Microscope And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4700 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HRM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5673 |
| Device | Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
| Product Code | HRM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Microscope And Accessories. |
| CFR Regulation Number | 878.4700 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 7 |
Component Falling | 6 |
Loose Or Intermittent Connection | 4 |
Microscope | 4 |
Device Inoperable | 3 |
Device Operational Issue | 3 |
Device Displays Incorrect Message | 3 |
Loss Of Power | 3 |
Off-Label Use | 3 |
Inadequate Or Insufficient Training | 3 |
Detachment Of Device Component | 2 |
Optical Problem | 2 |
Unintended System Motion | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Device Dislodged Or Dislocated | 2 |
Inadequate Lighting | 1 |
Appropriate Term/Code Not Available | 1 |
Heads | 1 |
Use Of Device Problem | 1 |
Connection Problem | 1 |
Bent | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Mechanics Altered | 1 |
Disconnection | 1 |
Unintended Arm Motion | 1 |
Misfocusing | 1 |
Insufficient Information | 1 |
| Total Device Problems | 61 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alcon Research Laboratories Ltd. | II | Feb-27-2019 |
| 2 | Alcon Research, Ltd. | II | Aug-28-2017 |
| 3 | Alcon Research, Ltd. | II | Aug-21-2015 |
| 4 | Leica Microsystems, Inc. | II | Feb-15-2019 |
| 5 | Leica Microsystems, Inc. | II | Jan-24-2019 |