Brand Name | VISUMAX LASER KERATOME |
Type of Device | FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION |
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 |
william
gustafson
|
5160 hacienda drive |
dublin, CA 94568
|
9255574689
|
|
MDR Report Key | 7001478 |
MDR Text Key | 91054060 |
Report Number | 9615030-2017-00023 |
Device Sequence Number | 1 |
Product Code |
OTL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P150040 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/25/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/03/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Catalogue Number | 000000-1345-518 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 10/25/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/13/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 31 YR |
|
|