Brand Name | ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM |
Type of Device | LENS, GUIDE, INTRAOCULAR |
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 | 7731118 |
MDR Text Key | 115369770 |
Report Number | 1119421-2018-01031 |
Device Sequence Number | 1 |
Product Code |
KYB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P930014 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/07/2018 |
2 Devices were Involved in the Event: |
1
2
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/31/2020 |
Device Model Number | AU00T0 |
Device Lot Number | 12567438 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/02/2018 |
Initial Date FDA Received | 07/30/2018 |
Supplement Dates Manufacturer Received | 09/11/2018
|
Supplement Dates FDA Received | 10/07/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/18/2017 |
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 |
Treatment | ZA9003 17.0REPLACEMENT LENS |
Patient Outcome(s) |
Required Intervention;
|
|
|