Brand Name | CONSTELLATION SURGICAL PROCEDURE PACK |
Type of Device | GENERAL SURGERY TRAY (KIT) |
Manufacturer (Section D) |
ALCON RESEARCH, LLC - HOUSTON |
9965 buffalo speedway |
houston TX 77054 |
|
Manufacturer (Section G) |
ALCON RESEARCH, LLC - HOUSTON |
9965 buffalo speedway |
|
houston TX 77054 |
|
Manufacturer Contact |
jonathan
schlech
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8007579780
|
|
MDR Report Key | 18805620 |
MDR Text Key | 336523665 |
Report Number | 1644019-2024-00366 |
Device Sequence Number | 1 |
Product Code |
LRO
|
UDI-Device Identifier | 00380657531066 |
UDI-Public | 00380657531066 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K880961 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
04/16/2024 |
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 | 04/30/2024 |
Device Catalogue Number | 8065753106 |
Device Lot Number | 14MKLV |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/06/2024 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/06/2024
|
Initial Date FDA Received | 02/29/2024 |
Supplement Dates Manufacturer Received | 03/20/2024
|
Supplement Dates FDA Received | 04/16/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/06/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | CONSTELLATION VISION SYSTEM |