Brand Name | ACRYSOF RESTOR 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 | 6355159 |
MDR Text Key | 68211207 |
Report Number | 1119421-2017-00278 |
Device Sequence Number | 1 |
Product Code |
MJP
|
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | P040020 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
10/19/2017 |
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 | SND1T5 |
Device Catalogue Number | SND1T5.195 |
Device Lot Number | 12383138 |
Other Device ID Number | 00380652271141 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/25/2017 |
Initial Date FDA Received | 02/23/2017 |
Supplement Dates Manufacturer Received | Not provided Not provided 09/20/2017
|
Supplement Dates FDA Received | 03/31/2017 05/01/2017 10/19/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/14/2015 |
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 |
Treatment | CENTURION; INFINITI |
Patient Outcome(s) |
Required Intervention;
|