Brand Name | IMPLANTABLE COLLAMER LENS (ICL) |
Type of Device | PHAKIC TORIC INTRAOCULAR LENS |
Manufacturer (Section D) |
STAAR SURGICAL COMPANY |
1911 walker avenue |
monrovia CA 91016 |
|
Manufacturer (Section G) |
STAAR SUGICAL COMPANY |
1911 walker avenue |
|
monrovia CA 91016 |
|
Manufacturer Contact |
joselene
muniz
|
1911 walker avenue |
monrovia, CA 91016
|
|
MDR Report Key | 19213492 |
MDR Text Key | 341516995 |
Report Number | 2023826-2024-02014 |
Device Sequence Number | 1 |
Product Code |
QCB
|
UDI-Device Identifier | 00840311307722 |
UDI-Public | 00840311307722 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P030016 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/11/2024 |
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 Model Number | VTICM5_12.6 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/23/2024 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/11/2024
|
Initial Date FDA Received | 04/30/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 09/18/2023 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | INJECTOR MODEL-LIOLI-24, LOT#-UNK. |
Patient Age | 33 YR |
Patient Sex | Female |