Brand Name | IMPLANTABLE COLLAMER LENS (ICL) |
Type of Device | PHAKIC TORIC INTRAOCULAR LENS |
Manufacturer (Section D) |
STAAR SURGICAL COMPANY |
1911 walker avenue |
monrovia CA 91016 |
|
MDR Report Key | 11654129 |
MDR Text Key | 245077578 |
Report Number | 2023826-2021-00955 |
Device Sequence Number | 1 |
Product Code |
QCB
|
UDI-Device Identifier | 00841542109369 |
UDI-Public | 00841542109369 |
Combination Product (y/n) | N |
PMA/PMN Number | P030016 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
03/23/2021 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/31/2022 |
Device Model Number | TMICL13.2 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/24/2021 |
Initial Date Manufacturer Received |
03/23/2021
|
Initial Date FDA Received | 04/12/2021 |
Supplement Dates Manufacturer Received | 04/21/2021 05/25/2021 09/17/2021
|
Supplement Dates FDA Received | 05/13/2021 06/17/2021 09/17/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK |
Patient Outcome(s) |
Required Intervention;
|