ALCON 8065740970Recalls & reported problems

Alcon Laboratories, Inc. · SILICONE I/A TIP STRAIGHT · Class 2

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380657409709), received between Oct 12, 2021 and Jan 9, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Material Fragmentation2
Defective Device1

Patient problems

Capsular Bag Tear2
Rupture1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryJan 9, 2023Defective Device; Defective Device
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY CAPSULAR RUPTURE AND BURR ON THE OPHTHALMIC TIP WAS OBSERVED. THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Rupture
MAUDE report 16119947 ↗
InjuryOct 12, 2021Material Fragmentation; Material Fragmentation
A SURGEON REPORTED THAT DURING A CATARACT SURGERY THE IRRIGATION AND ASPIRATION TIP EXHIBITED A METAL SHARD WHICH RESULTED IN A CAPSULAR TEAR. THE SURGERY WAS COMPLETED WITH A THREE PIECE INTRA OCULAR LENS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SHARD MIGHT BE EITHER METAL OR PLASTIC LOCATED ON THE BACK SIDE OF THE SILICONE TIP.
Patient problems: Capsular Bag Tear
MAUDE report 12619757 ↗
InjuryOct 12, 2021Material Fragmentation; Material Fragmentation
A SURGEON REPORTED THAT DURING TWO SEPARATE CATARACT SURGERIES THE IRRIGATION AND ASPIRATION TIPS EXHIBITED A METAL SHARD WHICH RESULTED IN CAPSULAR TEARS. THE SURGERIES WERE COMPLETED BY USING A THREE PIECE INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 12619752 ↗

Device details

UDI-DI	`00380657409709`
Brand	ALCON
Model	8065740970
Company	Alcon Laboratories, Inc.
Product code	NKK · NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 7, 2019

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

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. 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 reusable device intended to be sterilized prior to use.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.