FDA Adverse Event
Injury
Summary report: N
SION SURGICAL INSTRUMENT
MDR report key: 23835045
·
Received December 17, 2025
Report
- Report Number
- 3010363671-2025-00017
- Event Type
- Injury
- Date Received
- December 17, 2025
- Date of Event
- November 19, 2025
- Report Date
- December 17, 2025
- Manufacturer
- SIGHT SCIENCES INC
- Product Code
- HMZ
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE PHYSICIAN WHO USED A SION DEVICE REPORTED THAT DURING USE OF THE DEVICE, THE TIP OF THE DEVICE BROKE APART IN THE ANGLE. THE SEVERED PART WAS REMOVED USING FORCEPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2248287 | SION SURGICAL INSTRUMENT | SION SURGICAL INSTRUMENT | HMZ | SIGHT SCIENCES INC | F25F20-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |