Brand Name | OMNI SURGICAL SYSTEM |
Type of Device | VISCOELASTIC INJECTOR |
Manufacturer (Section D) |
SIGHT SCIENCES, INC. |
3000 sand hill rd., 3-105 |
menlo park CA 94025 |
|
Manufacturer (Section G) |
SIGHT SCIENCES, INC. |
3000 sand hill rd., 3-105 |
|
menlo park CA 94025 |
|
Manufacturer Contact |
anne-marie
ripley
|
3000 sand hill rd., 3-105 |
menlo park, CA 94025
|
6616458546
|
|
MDR Report Key | 8254038 |
MDR Text Key | 133339974 |
Report Number | 3010363671-2019-00001 |
Device Sequence Number | 1 |
Product Code |
MRH
|
UDI-Device Identifier | 00858027006310 |
UDI-Public | (01)00858027006310 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K173332 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/16/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/31/2020 |
Device Model Number | 05600 |
Device Catalogue Number | 1-100 |
Device Lot Number | 1006652 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/02/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/18/2018 |
Initial Date FDA Received | 01/16/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/13/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 60 YR |
|
|