Brand Name | CENTURION VISION SYSTEM, HANDPIECE TIP |
Type of Device | UNIT, PHACOFRAGMENTATION |
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 | 18843032 |
MDR Text Key | 337084295 |
Report Number | 2523835-2024-00251 |
Device Sequence Number | 1 |
Product Code |
HQC
|
UDI-Device Identifier | 00380657508532 |
UDI-Public | 00380657508532 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K121555 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/05/2024 |
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 | 8065750853 |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/09/2024
|
Initial Date FDA Received | 03/05/2024 |
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 | C-PAK SURG PROC PACK; CEN VISION SYS, ACCE, ACTIVE SENTRY HP; CEN VISION SYS, ACCESSORY, ACTIVE SENTRY HP; CEN VISION SYS, ACTIVE SENTRY HP; CENVISION SYSTEM, ACCESSORY, ACTIVE SENTRY HP; CUSTOM-PAK |
|
|