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 |
|
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 | 14201639 |
MDR Text Key | 290041960 |
Report Number | 1119421-2022-00843 |
Device Sequence Number | 1 |
Product Code |
KYB
|
UDI-Device Identifier | 00380652394727 |
UDI-Public | 00380652394727 |
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
|
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/26/2022 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | AU00T0 |
Device Lot Number | 15318269 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/15/2022 |
Initial Date Manufacturer Received |
04/04/2022 |
Initial Date FDA Received | 04/26/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/07/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | DISCOVISC; ORA SYSTEM |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 75 YR |
Patient Sex | Male |