Brand Name | MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C |
Type of Device | FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) |
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
|
8007579780
|
|
MDR Report Key | 18397287 |
MDR Text Key | 331393813 |
Report Number | 1119421-2023-02223 |
Device Sequence Number | 1 |
Product Code |
MSS
|
UDI-Device Identifier | 00380659777622 |
UDI-Public | 00380659777622 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K112977 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/18/2024 |
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 | 8065977762 |
Device Lot Number | 15664823 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/03/2023
|
Initial Date FDA Received | 12/27/2023 |
Supplement Dates Manufacturer Received | 02/22/2024
|
Supplement Dates FDA Received | 03/18/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/05/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | ACRYSOF IQ NATURAL SINGLEPIECE IOL.; MONARCH III INJECTOR.; VISCOAT. |