Brand Name | MONARCH III "D" |
Type of Device | DELIVERY SYSTEM CARTRIDGE |
Manufacturer (Section D) |
ALCON RESEARCH, LTD. |
714 columbia ave. |
sinking spring PA 19608 |
|
MDR Report Key | 6364226 |
MDR Text Key | 68504249 |
Report Number | 6364226 |
Device Sequence Number | 1 |
Product Code |
KYB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/13/2017,02/23/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 09/30/2021 |
Device Catalogue Number | 8065977763 |
Device Lot Number | 32500961 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 02/13/2017 |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/13/2017 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 02/28/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | ARTIFICIAL LENS, LUBRICANT, DELIVERY SYSTEM CARTRI |
Patient Age | 65 YR |
Patient Weight | 114 |
|
|