Brand Name | STELLARIS VISION ENHANCEMENT SYSTEM |
Type of Device | UNIT, PHACOFRAGMENTATION |
Manufacturer (Section D) |
BAUSCH + LOMB |
rochester NY 14609 |
|
Manufacturer (Section G) |
ST. LOUIS |
3365 treecourt industrial blvd |
|
st. louis MO 63122 |
|
Manufacturer Contact |
sharon
spencer
|
50 technology drive west |
irvine, CA 92618
|
|
MDR Report Key | 5886165 |
MDR Text Key | 52441638 |
Report Number | 0001920664-2016-00305 |
Device Sequence Number | 1 |
Product Code |
HQC
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K063331 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
07/22/2016 |
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 | 07/10/2017 |
Device Model Number | BL5114 |
Device Lot Number | V6320 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/22/2016
|
Initial Date FDA Received | 08/18/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/10/2016 |
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 |