Brand Name | FLEXIBLE IRIS RETRACTOR |
Type of Device | CLIP, IRIS RETRACTOR |
Manufacturer (Section D) |
ALCON GRIESHABER AG |
winkelriedstrasse 52 |
schaffhausen 8203 |
SZ 8203 |
|
Manufacturer (Section G) |
ALCON GRIESHABER AG |
winkelriedstrasse 52 |
|
schaffhausen 8203 |
SZ
8203
|
|
Manufacturer Contact |
jonathan
schlech
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8007579780
|
|
MDR Report Key | 15300443 |
MDR Text Key | 305372256 |
Report Number | 3003398873-2022-00062 |
Device Sequence Number | 1 |
Product Code |
HOC
|
UDI-Device Identifier | 07612717012226 |
UDI-Public | 07612717012226 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
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 |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
11/25/2022 |
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 | 01/31/2023 |
Device Catalogue Number | 611.74 |
Device Lot Number | F199527 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/04/2022
|
Initial Date FDA Received | 08/26/2022 |
Supplement Dates Manufacturer Received | 10/31/2022
|
Supplement Dates FDA Received | 11/25/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/19/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|