Brand Name | ACRYSOF IQ TORIC SINGLEPIECE IOL |
Type of Device | LENS, INTRAOCULAR, TORIC OPTICS |
Manufacturer (Section D) |
ALCON LABORATORIES IRELAND LTD. |
cork business&technology park |
model farm road |
cork 00000 |
EI 00000 |
|
Manufacturer (Section G) |
ALCON LABORATORIES IRELAND LTD. |
cork business&technology park |
model farm road |
cork 00000 |
EI
00000
|
|
Manufacturer Contact |
cindy
milam
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8176152231
|
|
MDR Report Key | 8538340 |
MDR Text Key | 142731149 |
Report Number | 9612169-2019-00067 |
Device Sequence Number | 1 |
Product Code |
MJP
|
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 |
health professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
04/22/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/22/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/31/2021 |
Device Model Number | SN6AT5 |
Device Catalogue Number | SN6AT5.180 |
Device Lot Number | 21167532 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/26/2019 |
Date Device Manufactured | 08/04/2016 |
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;
|