Brand Name | VISX EXCIMER LASER |
Manufacturer (Section D) |
AMO MANUFACTURING USA, LLC |
510 cottonwood drive |
milpitas CA 92705 493 |
|
Manufacturer (Section G) |
AMO MANUFACTURING USA, LLC |
510 cottonwood drive |
|
milpitas CA 92705 493 |
|
Manufacturer Contact |
carol
kail
|
1700 e st andrew place |
santa ana, CA 92705-4933
|
7142478598
|
|
MDR Report Key | 2339383 |
MDR Text Key | 2363141 |
Report Number | 3006695864-2011-00109 |
Device Sequence Number | 1 |
Product Code |
LZS
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | K000327 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User facility |
Reporter Occupation |
OTHER HEALTH CARE PROFESSIONAL
|
Type of Report
| Initial |
Report Date |
09/29/2011 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 10/24/2011 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | STAR S4 IR |
Device Catalogue Number | 0030-1479 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Event Location |
Outpatient Treatment Facility
|
Date Report TO Manufacturer | 09/29/2011 |
Date Manufacturer Received | 09/29/2011 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 08/01/1999 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|