FDA Adverse Event
Injury
Summary report: Y
TANGIBLE FILL
MDR report key: 24761352
·
Received April 1, 2026
Report
- Report Number
- 3016440358-2026-00001
- Event Type
- Injury
- Date Received
- April 1, 2026
- Date of Event
- February 23, 2026
- Report Date
- March 31, 2026
- Manufacturer
- DRY EYE INNOVATIONS
- Product Code
- MRC
- UDI-DI
- 00198168143803
- PMA / PMN Number
- K201069
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING FILED IMMEDIATELY AFTER THE MANUFACTURER WAS GRANTED ACCESS TO NEXGEN/WEBTRADER.
Description of Event or Problem · 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227977 | TANGIBLE FILL | SCLERAL SALINE | MRC | DRY EYE INNOVATIONS | 2090 | L684 | 00198168143803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Female | Other |