Brand Name | DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS |
Type of Device | DEVICE, IRRIGATION, OCULAR SURGERY |
Manufacturer (Section D) |
ALCON RESEARCH, LLC - ALCON PRECISION DEVICE |
714 columbia avenue |
sinking spring PA 19608 |
|
Manufacturer (Section G) |
ALCON RESEARCH, LLC - ALCON PRECISION DEVICE |
714 columbia avenue |
|
sinking spring PA 19608 |
|
Manufacturer Contact |
jonathan
schlech
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8007579780
|
|
MDR Report Key | 13391327 |
MDR Text Key | 284677701 |
Report Number | 2523835-2022-00032 |
Device Sequence Number | 1 |
Product Code |
KYG
|
Combination Product (y/n) | N |
Reporter Country Code | PL |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/11/2022 |
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 Catalogue Number | ALCUNK00787 |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/20/2022
|
Initial Date FDA Received | 01/31/2022 |
Supplement Dates Manufacturer Received | 04/14/2022
|
Supplement Dates FDA Received | 05/11/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | SURGICAL PRODUCT, UNSPECIFIED |