MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-27 for SOFTEC I SOFTECI+20.0 manufactured by Lenstec Barbados Inc..
| Report Number | 9613160-2020-00010 |
| MDR Report Key | 9889562 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-11-26 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JIMMY CHACKO |
| Manufacturer Street | 1765 COMMERCE AVE. N. |
| Manufacturer City | ST. PETERSBURG, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 5712272 |
| Manufacturer G1 | LENSTEC BARBADOS INC. |
| Manufacturer Street | AIRPORT COMMERCIAL CENTRE PILGRIM ROAD |
| Manufacturer City | CHRIST CHURCH, |
| Manufacturer Country | BB |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFTEC I |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HQL |
| Date Received | 2020-03-27 |
| Model Number | SOFTECI+20.0 |
| Catalog Number | SOFTEC I |
| Lot Number | SB08234 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LENSTEC BARBADOS INC. |
| Manufacturer Address | AIRPORT COMMERCIAL CENTRE PILGRIM ROAD CHRIST CHURCH, BB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |