Brand Name | INTREPID AUTOSERT IOL HANDPIECE, I/A TIP |
Type of Device | APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED |
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 | 13885275 |
MDR Text Key | 287796376 |
Report Number | 2028159-2022-00410 |
Device Sequence Number | 1 |
Product Code |
HQC
|
UDI-Device Identifier | 00380657510139 |
UDI-Public | 00380657510139 |
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | K112425 |
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 |
08/09/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/24/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 8065751012 |
Device Lot Number | 13YJ9R |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/14/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/15/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|