LACRIFLOW LF-R090ARecalls & reported problems

Kaneka Corporation · The LACRIFLOW is indicated in treatments of epiphora in-patients 12 months and older, in cases of: - Canalicular pathologies (stenosis, obstruction, lacerations), - During Dacryocystorhinostomy (conventional or laser), - Congenital nasolacrimal duct obstruction. · Class U · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04540778140875), received between Jun 2, 2021 and Jun 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

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 16, 2026.

Most reported problems

Device problems

Improper or Incorrect Procedure or Method2

Patient problems

Foreign Body In Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryJun 15, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE DOCTOR FELT THE BOUGIE PIERCED THROUGH THE TUBE AS SHE ADVANCED THE LACRIMAL TUBE. SHE RECOVERED THE LACRIMAL TUBE FROM THE PATIENT'S LACRIMAL DUCT AND FOUND THAT IT HAD A HOLE. WHEN THE ACTUAL DEVICE USED WAS INVESTIGATED, THE RING WAS DISMOUNTED AND MISSING. THE RING'S WHEREABOUTS WAS NOT CONFIRMED DURING THE PROCEDURE IN THIS EYE CLINIC, AND ACCORDINGLY, IT HAS A POSSIBILITY THAT THE MISSING STAINLESS STEEL RING MIGHT HAVE BEEN REMAINING IN THE PATIENT BODY. THIS DEVICE IS THE SAME DEVICE AS THE US NAME LACRIFLOW (510 (K) # K120886).
Patient problems: Foreign Body In Patient
MAUDE report 12005913 ↗
InjuryJun 2, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE DOCTOR FELT THE BOUGIE PIERCED THROUGH THE TUBE AS HE ADVANCED THE LACRIMAL TUBE. SHE RECOVERED THE LACRIMAL TUBE FROM THE PATIENT'S LACRIMAL DUCT AND FOUND THAT SHE HAD A HOLE. WHEN THE ACTUAL DEVICE USED WAS INVESTIGATED, THE RING WAS DISMOUNTED AND MISSING. THE RING'S WHEREABOUTS WAS NOT CONFIRMED DURING THE PROCEDURE IN THIS EYE CLINIC, AND ACCORDINGLY, IT HAS A POSSIBILITY THAT THE MISSING STAINLESS STEEL RING MIGHT HAVE BEEN REMAINING IN THE PATIENT BODY. THIS DEVICE IS THE SAME DEVICE AS THE US NAME LACRIFLOW (510 (K) # K120886).
Patient problems: Foreign Body In Patient
MAUDE report 11918460 ↗

Device details

UDI-DI	`04540778140875`
Brand	LACRIFLOW
Model	LF-R090A
Company	Kaneka Corporation
Product code	OKS · Lacrimal Stents And Intubation Sets
Class	Class U
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Sep 11, 2023

Device type (GMDN): Lacrimal tube

An implantable short tube intended to provide a bypass route for tear drainage from the corner of the eye into the nasal cavity, or a paranasal sinus, as treatment for pathologies of the tear drainage system in association with functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent (e.g., Lester Jones type), it is implanted after surgery to dilate or maintain a surgically-created passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer materials (e.g., silicone).

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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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