Brand Name | VALVED ENTRY SYSTEM |
Type of Device | CANNULA, TROCAR, OPHTHALMIC |
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 |
cindy
milam
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8176152231
|
|
MDR Report Key | 8946455 |
MDR Text Key | 156402752 |
Report Number | 2028159-2019-01590 |
Device Sequence Number | 1 |
Product Code |
NGY
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/03/2019 |
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 Catalogue Number | ASKU |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/04/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/23/2019 |
Initial Date FDA Received | 08/29/2019 |
Supplement Dates Manufacturer Received | 11/25/2019
|
Supplement Dates FDA Received | 12/03/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|