Synergetics 58.20Recalls & reported problems

Synergetics USA, Inc. · ONE-STEP™ Sutureless Cannula System · Class 1

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 10841305101675), received between Sep 4, 2024 and Sep 4, 2024 — 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Fragmentation1

Patient problems

Insufficient Information1

Recent adverse event reports

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

InjurySep 4, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED BY THE USER FACILITY THAT THE CANULA BROKE OUT OF THE TROCAR AND WAS IN TISSUE OF THE RIGHT EYE. THE DOCTOR HAD TO REMOVE THE PRODUCT FROM THE TISSUE WITH FORCEPS AND ONE VICRYL WAS NEEDED.
Patient problems: Insufficient Information
MAUDE report 20138421 ↗

Device details

UDI-DI	`10841305101675`
Brand	Synergetics
Model	58.20
Company	Synergetics USA, Inc.
Product code	MDM · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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	Apr 4, 2025

Device type (GMDN): Ophthalmic soft-tissue manipulation forceps, probe-like, single-use

A sterile, hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small jaw-like grasping blades that protrude from the distal end of the shaft. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.