Sion Surgical Instrument FG 08255Recalls & reported problems

Sight Sciences, Inc. · The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument. · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858027006501), received between Nov 13, 2025 and Nov 13, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Fragmentation1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryNov 13, 2025Material Fragmentation; Material Fragmentation
THE PHYSICIAN REPORTED THAT DURING USE OF THE SION DEVICE, THE DISTAL TIP BROKE OFF WHILE THE DEVICE WAS IN THE ANTERIOR CHAMBER. THE BREAKAGE WAS NOTICED PRIOR TO STARTING THE PROCEDURE. THE BROKEN PIECE WAS REMOVED FROM THE ANTERIOR CHAMBER BY USING VISCOELASTIC TO PUSH IT OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23550245 ↗

Device details

UDI-DI	`00858027006501`
Brand	Sion Surgical Instrument
Model	FG 08255
Catalog no.	1-107
Company	Sight Sciences, Inc.
Product code	HMZ · Trabeculotome
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 22, 2023

Device type (GMDN): Trabeculotome, single-use

A hand-held manual ophthalmic surgical instrument intended to be used to perform a trabeculotomy, via transluminal access through Schlemm's canal (sinus venosus sclerae) and piercing of the trabecular meshwork, to reduce intraocular pressure (IOP) for the prevention/treatment of glaucoma. It is made of metal and plastic materials, and is in the form of a handle with a thin, flexible, extendable tip at the distal end designed to be progressively inserted into the eye through a corneal incision. This is a single-use device.

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All Trabeculotome devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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