N
Patient 0
THIS REPORT IS BEING FILED IMMEDIATELY AFTER THE MANUFACTURER WAS GRANTED ACCESS TO NEXGEN/WEBTRADER.
MAUDE MDR 24761352
- MDR report key
- 24761352
- Report number
- 3016440358-2026-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-02-23
- Date received
- 2026-04-01
- Adverse event
- 1
- Product problem
- 0
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- MS ROSEMARY HAYES
- Address
- 5051 KATHRYN AVE FRANKLIN TN 37064 US
- Phone
- 855-855-8555
- Report source
- M
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 227977 | TANGIBLE FILL | SCLERAL SALINE | DRY EYE INNOVATIONS | MRC | 2090 | L684 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2026-04-01 | 0 | O |
Event Narratives#
D
Patient 0
CUSTOMER REPORTED: THEY HAVE BEEN USING TANGIBLE FILL FOR FIVE MONTHS AND RECENTLY ON INSERTING THE EYE BURNED LIKE IT WAS THE CLEAR CARE SHE SOAKS THEM IN OVERNIGHT. THE LENS WAS REMOVED, EYE WAS BLOODSHOT. THEY USED ANOTHER VIAL FROM THE SAME LOT IN THEIR OTHER EYE WITHOUT ISSUE AFTER RINSING. THE LOT WAS L684.