Brand Name | IOLMASTER 700 |
Type of Device | IOLMASTER 700 |
Manufacturer (Section D) |
CARL ZEISS MEDITEC AG (JENA) |
carl zeiss promenade 10 |
jena, thueringia 7745 |
GM 7745 |
|
Manufacturer (Section G) |
CARL ZEISS MEDITEC AG (JENA) |
carl zeiss promenade 10 |
|
jena, thueringia 7745 |
GM
7745
|
|
Manufacturer Contact |
manjaya
hegde
|
5300 central parkway |
dublin, CA 94568
|
9252164697
|
|
MDR Report Key | 18895973 |
MDR Text Key | 337573880 |
Report Number | 9615030-2024-00004 |
Device Sequence Number | 1 |
Product Code |
HJO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K170171 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
04/10/2024 |
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 | 700 |
Device Catalogue Number | 000000-1932-169 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/13/2024 |
Initial Date FDA Received | 03/13/2024 |
Supplement Dates Manufacturer Received | 03/22/2024
|
Supplement Dates FDA Received | 04/10/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/29/2018 |
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;
|
|
|