Alcon 8065445520Recalls & reported problems

Alcon Laboratories, Inc. · Microsurgical Instrument CAPSULORHEXIS CYSTITOME 25GA FORMED · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380654455204), received between Aug 9, 2024 and Aug 9, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Obstruction of Flow1

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.

MalfunctionAug 9, 2024Obstruction of Flow; Obstruction of Flow
A NURSE REPORTED THAT FIFTEEN OPHTHALMIC SURGICAL SHORT NEEDLES/CANNULAS WERE CLOGGED. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER NEEDLE. IT WAS ALSO REPORTED THAT THEY HAD TO BE CHANGED OUT FOR EVERY CASE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19948849 ↗

Device details

UDI-DI	`00380654455204`
Brand	Alcon
Model	8065445520
Company	Alcon Laboratories, Inc.
Product code	HNY · Cystotome
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	Not in Commercial Distribution
Record updated	Mar 22, 2024

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.

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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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