Brand Name | ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM |
Type of Device | LENS, GUIDE, INTRAOCULAR |
Manufacturer (Section D) |
ALCON RESEARCH, LLC - HUNTINGTON |
6065 kyle lane |
huntington WV 25702 |
|
Manufacturer (Section G) |
ALCON RESEARCH, LLC - HUNTINGTON |
6065 kyle lane |
|
huntington WV 25702 |
|
Manufacturer Contact |
jonathan
schlech
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8175514979
|
|
MDR Report Key | 10778453 |
MDR Text Key | 216317506 |
Report Number | 1119421-2020-01599 |
Device Sequence Number | 1 |
Product Code |
KYB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P930014 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
11/03/2020 |
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 | 06/12/2023 |
Device Model Number | AU00T0 |
Device Lot Number | 15077032 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/08/2020 |
Initial Date FDA Received | 11/03/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/12/2020 |
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 |
|
|