Brand Name | ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C 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 | 14877069 |
MDR Text Key | 295065098 |
Report Number | 1119421-2022-01428 |
Device Sequence Number | 1 |
Product Code |
KYB
|
UDI-Device Identifier | 00380652249188 |
UDI-Public | 00380652249188 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P930014 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
09/06/2022 |
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 | SN6CWS |
Device Catalogue Number | SN6CWS.185 |
Device Lot Number | 12750108 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/07/2022
|
Initial Date FDA Received | 06/30/2022 |
Supplement Dates Manufacturer Received | 08/14/2022
|
Supplement Dates FDA Received | 09/06/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/17/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | ACRYSOF IOL W/ACRYSERT DELIVERY SYSTEM |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Male |
|
|