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 |
rita
lopez
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8175514846
|
|
MDR Report Key | 6228995 |
MDR Text Key | 64054172 |
Report Number | 9612169-2017-00006 |
Device Sequence Number | 1 |
Product Code |
MJP
|
Combination Product (y/n) | N |
Reporter Country Code | CI |
PMA/PMN Number | P930014 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
02/16/2017 |
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 Expiration Date | 06/30/2020 |
Device Model Number | SN6AT4 |
Device Catalogue Number | SN6AT4.220 |
Device Lot Number | 21136583 |
Other Device ID Number | 380652250467 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/14/2016 |
Initial Date FDA Received | 01/06/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 02/16/2017
|
Date Device Manufactured | 07/24/2015 |
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) |
Disability;
|
|
|