Brand Name | ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL |
Type of Device | INTRAOCULAR LENS |
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 | 11574643 |
MDR Text Key | 242414155 |
Report Number | 1119421-2021-00652 |
Device Sequence Number | 1 |
Product Code |
HQL
|
UDI-Device Identifier | 00380652332682 |
UDI-Public | 00380652332682 |
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
|
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/26/2021 |
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 Model Number | SA60WF |
Device Catalogue Number | SA60WF.210 |
Device Lot Number | 15048550 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/08/2021 |
Initial Date FDA Received | 03/26/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/04/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; UNSPECIFIED I/A |