The Recall Desk
HighFDA (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.

What this means for you

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

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.

Related recalls

Same category