MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-06 for ILUX SYSTEM 1.5 DEVICE 2020 manufactured by Tear Film Innovations Inc.
| Report Number | 3014322342-2019-00001 |
| MDR Report Key | 9287941 |
| Date Received | 2019-11-06 |
| Date of Report | 2019-11-06 |
| Date Mfgr Received | 2019-10-08 |
| Device Manufacturer Date | 2019-04-19 |
| Date Added to Maude | 2019-11-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| Manufacturer G1 | TEAR FILM INNOVATIONS INC |
| Manufacturer Street | 5924 BALFOUR COURT SUITE 100 |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ILUX SYSTEM 1.5 DEVICE |
| Generic Name | EYELID THERMAL PULSATION SYSTEM |
| Product Code | ORZ |
| Date Received | 2019-11-06 |
| Returned To Mfg | 2019-10-18 |
| Model Number | 1.5 |
| Catalog Number | 2020 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEAR FILM INNOVATIONS INC |
| Manufacturer Address | 5924 BALFOUR COURT SUITE 100 CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-06 |