Brand Name | IMPLANTABLE COLLAMER LENS |
Type of Device | 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 |
cynthia
thai
|
1911 walker avenue |
monrovia, CA 91016
|
8002927902
|
|
MDR Report Key | 7356128 |
MDR Text Key | 102992506 |
Report Number | 2023826-2018-00433 |
Device Sequence Number | 1 |
Product Code |
MTA
|
Combination Product (y/n) | N |
Reporter Country Code | LE |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
02/23/2018 |
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 |
Physician
|
Device Expiration Date | 10/31/2020 |
Device Model Number | VTICMO12.1 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/27/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/23/2018
|
Initial Date FDA Received | 03/20/2018 |
Supplement Dates Manufacturer Received | 04/04/2018 05/21/2018
|
Supplement Dates FDA Received | 05/03/2018 05/24/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/05/2017 |
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 | 34 YR |