Streamline Surgical System 10-0066Recalls & reported problems

New World Medical, Incorporated · Streamline · Class 2

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 00892064002102), received between Mar 13, 2026 and Mar 13, 2026 — classified as 1 injury.

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

Adverse Event Without Identified Device or Use Problem1

Patient problems

Eye Injury1

Recent adverse event reports

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

InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
DR. (B)(6) DECEMET'S DETACHMENT. THE SURGEON/CUSTOMER IS NOT EXPECTING FOLLOW-UP COMMUNICATION.
Patient problems: Eye Injury
MAUDE report 24598467 ↗

Device details

UDI-DI	`00892064002102`
Brand	Streamline Surgical System
Model	10-0066
Company	New World Medical, Incorporated
Product code	MRH · Pump, infusion, ophthalmic
Class	Class 2
FDA submission	K211680
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	Feb 24, 2025

Device type (GMDN): Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Other Pump, infusion, ophthalmic devices

OMNI Surgical System FG 07441
Sight Sciences, Inc. · Pump, Infusion, Ophthalmic
25 reports
VISCO(TM)360 Viscosurgical System FG 03916
Sight Sciences, Inc. · Pump, Infusion, Ophthalmic
23 reports
VIA360 Surgical System
New World Medical, Incorporated · Pump, infusion, ophthalmic
3 reports
OMNI Edge Surgical System 1-112
Sight Sciences, Inc. · Pump, Infusion, Ophthalmic
2 reports

All Pump, infusion, ophthalmic 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.

How reports and recalls are matched · Editorial policy · Report an error on this page