AcrySof™ IQ Vivity™ DFT015 (REF DFT015.255)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652421348), received between May 30, 2024 and Mar 31, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Damaged Prior to Use1
- Failure to Eject1
- Material Twisted/Bent1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Material Twisted/Bent
A NURSE REPORTED THAT BEFORE THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PHYSICIAN NOTICED THAT THE HAPTIC WAS DAMAGED. THE SURGERY WAS NOT COMPLETED AND THE PATIENT WAS LEFT APHAKIC. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744344 ↗MalfunctionJul 24, 2024Failure to Eject; Failure to Eject
A PHARMACIST REPORTED THAT DURING SURGERY, THEY NOTICED A PLACEMENT FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19817596 ↗InjuryMay 30, 2024Device Damaged Prior to Use; Device Damaged Prior to Use
A PHYSICIAN REPORTED THAT DURING SURGERY, IT WAS FOUND THAT ONE OF THE HAPTIC OF THE IOL BROKEN WHEN OPENED THE WHEEL, AND FOUND SEPARATELY IN THE WHEEL. ALSO SEVERE DAMAGE OBSERVED TO THE EDGE OF OPTIC. PATIENT LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT DOCTOR HAD SENT THE PATIENT WITHOUT IMPLANTING LENS. FOUR DAYS LATER, THE PATIENT WAS IMPLANTED ANOTHER LENS COMPANY MONOFOCAL LENS WAS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 19422577 ↗
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens93 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens89 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens87 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.