Brand Name | IOLMASTER 500 |
Type of Device | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
Manufacturer (Section D) |
CARL ZEISS MEDITEC AG (JENA) |
carl zeiss promenade 10 |
jena, thueringia 07745 |
GM 07745 |
|
Manufacturer (Section G) |
CARL ZEISS MEDITEC AG (JENA) |
carl zeiss promenade 10 |
|
jena, thueringia 07745 |
GM
07745
|
|
Manufacturer Contact |
manjaya
hegde
|
5300 central parkway |
dublin, CA 94568
|
9252164697
|
|
MDR Report Key | 17397691 |
MDR Text Key | 319797620 |
Report Number | 9615030-2023-00006 |
Device Sequence Number | 1 |
Product Code |
HJO
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K122418 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
07/26/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 500 |
Device Catalogue Number | 000000-1692-983 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/27/2023
|
Initial Date FDA Received | 07/26/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/02/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|