Brand Name | ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM |
Type of Device | LENS, GUIDE, INTRAOCULAR |
Manufacturer (Section D) |
ALCON RESEARCH, LLC - HUNTINGTON |
6065 kyle lane |
huntington WV 25702 |
|
MDR Report Key | 10731608 |
MDR Text Key | 212961434 |
Report Number | 1119421-2020-01543 |
Device Sequence Number | 1 |
Product Code |
KYB
|
Combination Product (y/n) | N |
PMA/PMN Number | P930014 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Type of Report
| Initial,Followup |
Report Date |
11/16/2020 |
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 | AU00T0 |
Device Lot Number | 12759080 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/21/2020 |
Initial Date Manufacturer Received |
10/08/2020 |
Initial Date FDA Received | 10/23/2020 |
Supplement Dates Manufacturer Received | 10/27/2020
|
Supplement Dates FDA Received | 11/16/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | UNSPECIFIED DISCOVISC OVD, 000545, UNK, BEL. |
Patient Outcome(s) |
Required Intervention;
|
|
|