Ngenuity 00380657530915Recalls & reported problems
Alcon Laboratories, Inc. · Microsurgical Camera · Class 1
All models of Ngenuity (3)
Data updated Oct 18, 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 00380657530915), received between Dec 28, 2023 and Dec 28, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Display or Visual Feedback Problem1
Patient problems
- Capsular Bag Tear1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
Other CAMERA, CINE, MICROSURGICAL, WITHOUT AUDIO devices
- NGENUITY 00380650003997Alcon Laboratories, Inc. · Camera, Cine, Microsurgical, Without Audio1 recall0 reports
- Ngenuity 00380650001139Alcon Laboratories, Inc. · CAMERA, CINE, MICROSURGICAL, WITHOUT AUDIO1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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