Brand Name | MICROSTAAR INJECTOR |
Type of Device | INTRAOCULAR LENS FOLDERS AND INJECTORS, PRODUCT CODE: MSS |
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
|
6263037902
|
|
MDR Report Key | 19067382 |
MDR Text Key | 339991214 |
Report Number | 2023826-2024-01575 |
Device Sequence Number | 1 |
Product Code |
MSS
|
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | K152357 |
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 |
Report Date |
03/12/2024 |
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 Model Number | SFC-45 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/12/2024 |
Initial Date FDA Received | 04/08/2024 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK; LENS MODEL VTICM5_13.2, SERIAL # (B)(6) |
Patient Age | 24 YR |
Patient Sex | Male |
|
|