AcrySof™ IQ Vivity™ DFT415 (REF DFT415.250)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652422154), received between Apr 13, 2022 and Apr 13, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision1
- Halo1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A CONSUMER REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BLURRY VISION BOTH FROM NEAR AND FAR, ESPECIALLY SEE THE SHADED LETTERS. SHE WAS ALSO SEEING FLASHES WHILE READING, PEELING APPLE AND SOMETIMES EVEN WHEN SHE LOOK AT SOMETHING FAR AWAY. PATIENT THINKS THAT, SOMETHING WENT WRONG DURING THE SURGERY; PERHAPS THE INSERTED LENS IS TOO LARGE FOR HER EYE OR MORE LIKELY, AND IT IS A FEELING THAT SHE HAS HAD SINCE THE BEGINNING, THAT THE LENS HAS MOVED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Halo; Visual Impairment
MAUDE report 14102695 ↗
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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
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 reports
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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