Brand Name | MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D |
Type of Device | FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) |
Manufacturer (Section D) |
ALCON RESEARCH, LLC - HUNTINGTON |
6065 kyle lane |
huntington WV 25702 |
|
MDR Report Key | 10460047 |
MDR Text Key | 205535702 |
Report Number | 1119421-2020-01195 |
Device Sequence Number | 1 |
Product Code |
MSS
|
Combination Product (y/n) | N |
PMA/PMN Number | K063155 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
10/15/2020 |
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 Catalogue Number | 8065977763 |
Device Lot Number | 32766575 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
08/27/2020
|
Initial Date FDA Received | 08/27/2020 |
Supplement Dates Manufacturer Received | 10/15/2020
|
Supplement Dates FDA Received | 10/15/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | (B)(6).; MONARCH III HANDPIECE.; PROVISC. |
Patient Age | 47 YR |
|
|