Brand Name | OMNI SURGICAL SYSTEM |
Type of Device | PUMP, INFUSION, OPHTHALMIC |
Manufacturer (Section D) |
SIGHT SCIENCES, INC. |
4040 campbell ave. |
suite 100 |
menlo park, ca |
|
Manufacturer (Section G) |
SIGHT SCIENCES, INC. |
4040 campbell ave. |
suite 100 |
menlo park, ca |
|
Manufacturer Contact |
edward
sinclair
|
4040 campbell ave. |
suite 100 |
menlo park, ca
|
2189149
|
|
MDR Report Key | 10105287 |
MDR Text Key | 193287991 |
Report Number | 3010363671-2020-00001 |
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 |
06/01/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/01/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 05600 |
Device Catalogue Number | 1-100 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/27/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 Outcome(s) |
Required Intervention;
Disability;
|
Patient Age | 50 YR |
|
|