Brand Name | MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D |
Type of Device | FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) |
Manufacturer (Section D) |
ALCON RESEARCH, LTD. - HUNTINGTON |
6065 kyle lane |
huntington WV 25702 |
|
Manufacturer (Section G) |
ALCON RESEARCH, LTD. - HUNTINGTON |
6065 kyle lane |
|
huntington WV 25702 |
|
Manufacturer Contact |
nadia
bailey
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8176152230
|
|
MDR Report Key | 7248976 |
MDR Text Key | 99801347 |
Report Number | 1119421-2018-00132 |
Device Sequence Number | 1 |
Product Code |
MSS
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | K063155 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
02/07/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/07/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2022 |
Device Catalogue Number | 8065977763 |
Device Lot Number | 32552376 |
Other Device ID Number | 8065977763 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/23/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/27/2017 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|