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 |
rita
lopez
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8175514846
|
|
MDR Report Key | 6485365 |
MDR Text Key | 72532967 |
Report Number | 1119421-2017-00499 |
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,other |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
07/10/2017 |
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 | 04/30/2019 |
Device Model Number | SN6AT5 |
Device Catalogue Number | SN6AT5.260 |
Device Lot Number | 12296335 |
Other Device ID Number | 00380652251112 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/03/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/16/2017 |
Initial Date FDA Received | 04/12/2017 |
Supplement Dates Manufacturer Received | 06/12/2017
|
Supplement Dates FDA Received | 07/10/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/28/2014 |
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 |
Treatment | MALYUGIN RING; MONARCH III D CARTRIDGE; MONARCH III IOL DELIVERY SYSTEM; UNSPECIFIED PROVISC |
Patient Outcome(s) |
Required Intervention;
|