Brand Name | EDGEPLUS 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 |
jonathan
schlech
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8007579780
|
|
MDR Report Key | 15561855 |
MDR Text Key | 301342850 |
Report Number | 2028159-2022-01420 |
Device Sequence Number | 1 |
Product Code |
NGY
|
UDI-Device Identifier | 00380657516582 |
UDI-Public | 00380657516582 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
01/16/2023 |
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 Expiration Date | 03/31/2023 |
Device Catalogue Number | 8065751658 |
Device Lot Number | 13VJ0D |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/15/2022 |
Initial Date FDA Received | 10/07/2022 |
Supplement Dates Manufacturer Received | 12/18/2022
|
Supplement Dates FDA Received | 01/16/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/22/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|