Ngenuity 00380650001139Recalls & 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 00380650001139), received between Sep 15, 2022 and Sep 15, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Intraocular Pressure Decreased1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 CAMERA, CINE, MICROSURGICAL, WITHOUT AUDIO devices
- NGENUITY 00380650003997Alcon Laboratories, Inc. · Camera, Cine, Microsurgical, Without Audio1 recall0 reports
- Ngenuity 00380657530915Alcon 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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