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 | 16403358 |
MDR Text Key | 309996686 |
Report Number | 2523835-2023-00080 |
Device Sequence Number | 1 |
Product Code |
HQC
|
UDI-Device Identifier | 00380657520664 |
UDI-Public | 00380657520664 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K121555 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial |
Report Date |
02/20/2023 |
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 | 8065752066 |
Device Lot Number | 14PM2D |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/20/2023 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/25/2023 |
Initial Date FDA Received | 02/20/2023 |
Date Device Manufactured | 05/19/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | CONSTELLATION SURGICAL PROCEDURE PACK; CUSTOM-PAK SURGICAL PROCEDURE PACK; CUSTOM-PAK SURGICAL PROCEDURE PACK |
Patient Age | 71 YR |
Patient Sex | Female |
Patient Weight | 57 KG |