Agency classClass IIOur severity:High FDA (Devices)·Z-2412-2024·Announced 2024-07-24

Surgical Image Guidance Software May Cause Incorrect Toric IOL Axis Placement

Surgical image guidance software in NGENUITY 3D systems may miscalculate lens axis placement during eye rotation, potentially causing astigmatic error and decreased visual acuity.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall affecting surgical guidance for IOL placement. The source describes potential for astigmatic error and decreased visual acuity from incorrect lens placement but does not report any illnesses or injuries, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Alcon Research LLC is recalling the Surgical Image Guidance Functionality software (Part Number 8065000399, Software Version 1.5) used with its NGENUITY 3D Visualization System. This software provides surgical guidance during intraocular lens (IOL) placement procedures.

A software anomaly may occur when significant eye rotation or movement happens after surgery initiation while the surgical image guidance is active. The anomaly can cause the software to re-establish an incorrect registration angle, making the range indicator display incorrectly. This could result in incorrect placement of the toric IOL axis, causing astigmatic error (under- or over-correction) and decreased uncorrected visual acuity.

Affected systems were distributed worldwide, including throughout the United States and to Canada, Japan, and France. The recall affects 230 units with specific serial numbers. Healthcare facilities using affected systems should verify correct IOL axis placement through alternative confirmation methods.

Alcon is implementing a software update and working with facilities on recall procedures. Healthcare providers should contact Alcon for guidance on verification and remediation.

The recalled product

Product: Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Manufacturer: Alcon Research LLC
Category: Medical Device — Surgical Guidance Software
Hazard: software-defect
surgical-guidance-error
intraocular-lens-misplacement
astigmatic-error
Affected units: 230

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI-DI: 00380650003997. Software Version: 1.5. Serial Numbers: 004-0680001
004-0680002
004-0680003
004-0680004
004-0680007
004-0680008
004-0680017
004-0680026
004-0680036
004-0680047
004-0680048
004-0680086
004-0680090
004-0680092
004-0680096
004-0680100
004-0680107
004-0680112
004-0680120
004-0680127

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Same manufacturer · Alcon Research LLC

See all →

Severe
GenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
Severe
Systane Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
Critical
Ophthalmic surgical packs recalled over incomplete seals affecting sterility
FDA (Devices) · 2025-12-31
Moderate
Vitrectomy probe packs recalled with no reason stated in the record
FDA (Devices) · 2025-12-03
High
Infusion line packs recalled over incomplete seals in sterile pouches
FDA (Devices) · 2025-11-05

Same hazard · software defect