Alcon 8065424620Recalls & reported problems

Alcon Laboratories, Inc. · Microsurgical Instrument IRR. CYSTITSOME 25GA FORMED REVERSE CUT SHORT RADIUS · Class 1

Data updated Oct 16, 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 00380654246208), received between Jul 9, 2025 and Jul 9, 2025 — 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 16, 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

Blurred Vision1
Conjunctivitis1
Corneal Edema1
Eye Pain1
Inflammation1
Intraocular Pressure Increased1
Red Eye(s)1
Toxic Anterior Segment Syndrome (TASS)1

Recent adverse event reports

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

InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION INDICATED THAT THE MOST RECENT CHART NOTE WAS FROM A NINE-DAY POSTOPERATIVE VISIT FOLLOWING INTRAOCULAR LENS (IOL) REPOSITIONING. THE BLURRINESS HAD IMPROVED, ALTHOUGH THE VISION REMAINED SOMEWHAT BLURRY. HOWEVER, THE GENERAL POSTOPERATIVE APPEARANCE WAS GOOD, WITH NO SIGNS OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS ADVISED TO RETURN FOR SERIAL REFRACTIONS AT FUTURE VISITS.
Patient problems: Blurred Vision; Conjunctivitis; Corneal Edema; Eye Pain; Inflammation; Intraocular Pressure Increased; Red Eye(s); Toxic Anterior Segment Syndrome (TASS)
MAUDE report 22460130 ↗

Device details

UDI-DI	`00380654246208`
Brand	Alcon
Model	8065424620
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 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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