Brand Name | ACRYSOF IQ TORIC SINGLEPIECE IOL |
Type of Device | LENS, INTRAOCULAR, TORIC OPTICS |
Manufacturer (Section D) |
ALCON RESEARCH, LTD. - HUNTINGTON |
6065 kyle lane |
huntington WV 25702 |
|
Manufacturer (Section G) |
ALCON RESEARCH, LTD. - HUNTINGTON |
6065 kyle lane |
|
huntington WV 25702 |
|
Manufacturer Contact |
eddie
darton, md, jd
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8175686660
|
|
MDR Report Key | 5210192 |
MDR Text Key | 30691262 |
Report Number | 1119421-2015-06550 |
Device Sequence Number | 1 |
Product Code |
MJP
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | P930014 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
12/17/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/09/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/31/2019 |
Device Model Number | SN6AT6 |
Device Catalogue Number | SN6AT6.235 |
Device Lot Number | 12310355 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/30/2015 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/02/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/07/2014 |
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;
|
Patient Age | 49 YR |
Patient Weight | 75 |
|
|