Brand Name | ICL (IMPLANTABLE COLLAMER LENS) |
Type of Device | INTRAOCULAR LENS |
Manufacturer (Section D) |
STAAR SURGICAL COMPANY |
1911 walker street |
monrovia, ca |
|
Manufacturer (Section G) |
STAAR SURGICAL COMPANY |
1911 walker street |
|
monrovia, ca |
|
Manufacturer Contact |
cynthia
thai
|
1911 walker avenue |
monrovia, ca
|
3037902237
|
|
MDR Report Key | 6453248 |
MDR Text Key | 203150797 |
Report Number | 2023826-2016-01554 |
Device Sequence Number | 1 |
Product Code |
QCB
|
Combination Product (y/n) | N |
PMA/PMN Number | NA |
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 |
10/13/2016 |
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 Expiration Date | 02/28/2018 |
Device Model Number | VTICMO13.2 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/26/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/13/2016
|
Initial Date FDA Received | 04/03/2017 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 03/23/2015 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 22 YR |
|
|