Brand Name | SOFTEC HDO |
Type of Device | INTRAOCULAR LENS |
Manufacturer (Section D) |
LENSTEC BARBADOS INC. |
airport commercial centre |
pilgrim road |
christ church, BB170 92, |
BB BB17092, |
|
Manufacturer (Section G) |
LENSTEC BARBADOS INC. |
airport commercial centre |
pilgrim road |
christ church, |
BB
|
|
Manufacturer Contact |
jimmy
chacko
|
1765 commerce ave. n. |
st. petersburg, fl
|
5712272
|
|
MDR Report Key | 10315945 |
MDR Text Key | 200427510 |
Report Number | 9613160-2020-00059 |
Device Sequence Number | 1 |
Product Code |
HQL
|
UDI-Device Identifier | 00844369037358 |
UDI-Public | 00844369037358 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P090022 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/23/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/23/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/05/2021 |
Device Model Number | SOFTECHDO+20.0 |
Device Catalogue Number | SOFTEC HDO |
Device Lot Number | F4177 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/06/2020 |
Date Manufacturer Received | 06/25/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/06/2016 |
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 |
|
|