Alcon 8065426620Recalls & reported problems

Alcon Laboratories, Inc. · Microsurgical Instrument IRR CYSTITOME 27GA REVERSE CUT DEEP-SET EYES · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380654266206), received between Oct 30, 2023 and Nov 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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

Dull, Blunt1
Material Protrusion/Extrusion1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

MalfunctionNov 22, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion
A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC CYSTOTOME WAS NOT CAUGHT IN THE SAC. AFTER SURGERY, DEFECT ON THE TIP WAS FOUND WITH SLIT. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18189802 ↗
MalfunctionOct 30, 2023Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY, SURGEON NOTICED THAT A BURR TIP OF BLADE. THE SURGERY WAS RESUMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18036202 ↗

Device details

UDI-DI	`00380654266206`
Brand	Alcon
Model	8065426620
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	In Commercial Distribution
Record updated	Aug 26, 2020

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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