Brand Name | ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC |
Type of Device | CANNULA, OPHTHALMIC |
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 | 18739389 |
MDR Text Key | 335840949 |
Report Number | 2523835-2024-00143 |
Device Sequence Number | 1 |
Product Code |
HMX
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/20/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/20/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 8065440220 |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/24/2024 |
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 | PROVISC OPHTHALMIC VISCOSURGICAL DEVICE |