Brand Name | IMPLANTABLE COLLAMER LENS (ICL) |
Type of Device | PHAKIC 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
enriquez
|
1911 walker avenue |
monrovia, CA 91016
|
|
MDR Report Key | 15562518 |
MDR Text Key | 301349109 |
Report Number | 2023826-2022-03520 |
Device Sequence Number | 1 |
Product Code |
MTA
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
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 |
09/09/2022 |
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 | VICM5 13.2 |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/09/2022 |
Initial Date FDA Received | 10/07/2022 |
Supplement Dates Manufacturer Received | 11/23/2022
|
Supplement Dates FDA Received | 11/23/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/14/2022 |
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.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK. |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 29 YR |
Patient Sex | Male |
|
|