AcrySof™ IQ Vivity™ DFT415 (REF DFT415.185)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · Class 3 · Implant
All models of AcrySof IQ Vivity (225)
Data updated Oct 16, 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 00380652422024), received between Aug 13, 2024 and Aug 13, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Device” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device1
Patient problems
- Blurred Vision1
- Diplopia/Double Vision1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2024Defective Device; Defective Device
ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT HAD CORNEAL EDEMA POST OPERATION. ADDITIONAL INFORMATION RECEIVED STATING THAT THE PATIENT THE STILL HAD CORNEA EDEMA TWO WEEKS POST OPERATION. EDEMA PROBABLY DUE TO SECOND SURGERY FOR LENS REMOVAL. PATIENT WAS ON HYPERTONIC SODIUM CHLORIDE EYE DROPS.
Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Disturbances
MAUDE report 19973688 ↗
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens75 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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