NGENUITY 00380650003997Recalls & reported problems
Alcon Laboratories, Inc. · Microsurgical Camera · Class 1
All models of Ngenuity (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's 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, 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 16, 2026.
Recalls naming this device
- 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 ↗
Other Camera, Cine, Microsurgical, Without Audio devices
- Ngenuity 00380657530915Alcon Laboratories, Inc. · CAMERA, CINE, MICROSURGICAL, WITHOUT AUDIO1 report
- 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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