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 |
cynthia
thai
|
1911 walker avenue |
monrovia, CA 91016
|
8002927902
|
|
MDR Report Key | 12807803 |
MDR Text Key | 282738798 |
Report Number | 2023826-2021-04262 |
Device Sequence Number | 1 |
Product Code |
MTA
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | N/A |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/18/2021 |
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 Operator |
Health Professional
|
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 |
05/19/2021
|
Initial Date FDA Received | 11/12/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |