Brand Name | INFINITI VISION SYSTEM |
Type of Device | UNIT, PHACOFRAGMENTATION |
Manufacturer (Section D) |
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
15800 alton parkway |
irvine CA 92618 |
|
Manufacturer (Section G) |
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
15800 alton parkway |
|
irvine CA 92618 |
|
Manufacturer Contact |
eddie
darton, md, jd
|
mail stop ab2-6 |
mail stop r3-48 |
fort worth, TX 76134
|
8175686660
|
|
MDR Report Key | 4738916 |
MDR Text Key | 5775202 |
Report Number | 2028159-2015-05863 |
Device Sequence Number | 1 |
Product Code |
HQC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K120912 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative,company representative |
Reporter Occupation |
Hospital Service Technician
|
Type of Report
| Initial,Followup |
Report Date |
09/15/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | V3.0 |
Device Catalogue Number | 8065752160 |
Other Device ID Number | 3.01 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/08/2015 |
Initial Date FDA Received | 04/30/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 09/15/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/29/2012 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|