Brand Name | ACRYSOF MULTIPIECE IOL |
Type of Device | INTRAOCULAR LENS |
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 |
bryan
blake
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8176152230
|
|
MDR Report Key | 7965063 |
MDR Text Key | 123695451 |
Report Number | 1119421-2018-01481 |
Device Sequence Number | 0 |
Product Code |
HQL
|
Reporter Country Code | SF |
PMA/PMN Number | P930014 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/28/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/31/2022 |
Device Model Number | MA60AC |
Device Catalogue Number | MA60AC.165 |
Device Lot Number | 12579236 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/30/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/17/2018 |
Initial Date FDA Received | 10/15/2018 |
Supplement Dates Manufacturer Received | 11/30/2018
|
Supplement Dates FDA Received | 12/28/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/27/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|