Brand Name | CONSTELLATION VISION SYSTEM |
Type of Device | UNIT, PHACOFRAGMENTATION |
Manufacturer (Section D) |
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
15800 alton parkway |
irvine CA 92618 |
|
Manufacturer (Section G) |
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
15800 alton parkway |
|
irvine CA 92618 |
|
Manufacturer Contact |
jonathan
schlech
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8007579780
|
|
MDR Report Key | 16466573 |
MDR Text Key | 310500963 |
Report Number | 2028159-2023-00273 |
Device Sequence Number | 1 |
Product Code |
HQC
|
UDI-Device Identifier | 00380657511501 |
UDI-Public | 00380657511501 |
Combination Product (y/n) | N |
Reporter Country Code | TU |
PMA/PMN Number | K101285 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/04/2023 |
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 Model Number | TABLETOP |
Device Catalogue Number | 8065751150 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/24/2023 |
Initial Date FDA Received | 03/02/2023 |
Supplement Dates Manufacturer Received | 04/10/2023
|
Supplement Dates FDA Received | 05/04/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/14/2012 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|