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 SURGICAL COMPANY |
1911 walker avenue |
|
monrovia CA 91016 |
|
Manufacturer Contact |
joselene
muniz
|
1911 walker avenue |
monrovia, CA 91016
|
|
MDR Report Key | 18129710 |
MDR Text Key | 328024640 |
Report Number | 2023826-2023-05005 |
Device Sequence Number | 1 |
Product Code |
QBC
|
UDI-Device Identifier | 00840311318827 |
UDI-Public | 00840311318827 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | P030016 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/26/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | VTICMO12.1 |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/26/2023
|
Initial Date FDA Received | 11/14/2023 |
Supplement Dates Manufacturer Received | 01/25/2024
|
Supplement Dates FDA Received | 01/26/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/31/2022 |
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 | CARTRIDGE MODEL#SFC-45, LOT#UNK.; FOAMTIPPLUNGER MODEL#FTP, LOT#UNK.; INJECTOR MODEL#MSI-PF, LOT#UNK. |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 32 YR |
Patient Sex | Female |