Brand Name | RAINDROP EYE IMPLANT |
Type of Device | IMPLANT, CORNEAL, REFRACTIVE |
Manufacturer (Section D) |
|
MDR Report Key | 11893070 |
MDR Text Key | 253138988 |
Report Number | MW5101561 |
Device Sequence Number | 1 |
Product Code |
LQE
|
Combination Product (y/n) | Y |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Type of Report
| Initial |
Report Date |
05/24/2021 |
2 Devices were Involved in the Event: |
1
2
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 05/26/2021 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Disability;
|
Patient Age | 56 YR |
|
|