NgenuityRecalls & reported problems across all models

We found 3 models of Ngenuity by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Sep 15, 2022 and Dec 28, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (1 report).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Ngenuity recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 23, 2024Open, Classified

   After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.

   Z-2412-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported Ngenuity problems

Ngenuity models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NGENUITY 00380650003997

  Camera, Cine, Microsurgical, Without Audio
  1 recall0 reports
• Ngenuity 00380650001139

  CAMERA, CINE, MICROSURGICAL, WITHOUT AUDIO
  1 report
• Ngenuity 00380657530915

  CAMERA, CINE, MICROSURGICAL, WITHOUT AUDIO
  1 report

Recent Ngenuity adverse event reports

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

• InjuryDec 28, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC VISUALIZATION SYSTEM 3D SCREEN TURNED DOUBLE SUDDENLY AND THE PATIENT HAD POSTERIOR CAPSULE RUPTURE DURING ASPIRATION STEP OF CATARACT SURGERY. THE SITUATION OF THE DOUBLE WAS RESOLVED AS SOON AS CHANGING TO THE KEYBOARD OPERATION, THE SCREEN BACKED TO THE 3D. THE SURGERY WAS COMPLETED ON THE SAME DAY.

  Patient problems: Capsular Bag Tear

  MAUDE report 18408231 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER VITREOUS RETINAL SURGERY A PATIENT DEVELOPED A LOW INTRAOCULAR PRESSURE (2-3 MM HG). THE CONSOLE HAD ISSUES WITH VIDEO.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 15425712 ↗

Other Alcon Laboratories, Inc. products

• Clareon1,142 models · 8,100 reports · 1 recall
• Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
• Constellation13 models · 2,176 reports · 4 recalls
• CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
• Centurion5 models · 1,967 reports
• ACRYSOF353 models · 1,890 reports
• AcrySof UltraSert102 models · 1,467 reports · 1 recall
• MONARCH III2 models · 1,380 reports · 1 recall