Brand Name | SILICONE IRRIGATION AND ASPIRATION TIPS |
Type of Device | DEVICE, IRRIGATION, OCULAR SURGERY |
Manufacturer (Section D) |
ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE |
714 columbia avenue |
sinking spring PA 19608 |
|
Manufacturer (Section G) |
ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE |
714 columbia avenue |
|
sinking spring PA 19608 |
|
Manufacturer Contact |
eddie
darton, md, jd
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8175686660
|
|
MDR Report Key | 5001074 |
MDR Text Key | 22883405 |
Report Number | 2523835-2015-00798 |
Device Sequence Number | 1 |
Product Code |
KYG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Followup |
Report Date |
11/23/2015 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2020 |
Device Catalogue Number | 8065740970 |
Device Lot Number | 112062M |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/13/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 11/23/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/08/2015 |
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 |
Treatment | AMO SOVEREIGN SYSTEM |
Patient Outcome(s) |
Other;
|