AcrySof™ IQ Vivity™ DFT315 (REF DFT315.190)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
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652421621), received between Aug 19, 2021 and Jul 24, 2025 — classified as 3 injuries, 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Failure to Align1
- Failure to Deliver1
- Malposition of Device1
- Scratched Material1
Patient problems
- Blurred Vision2
- Visual Disturbances2
- Visual Impairment2
- Halo1
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2025Failure to Deliver; Scratched Material; Failure to Deliver; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN THE CARTRIDGE. THE LENS HAD SCRATCHES MAKING IT IMPOSSIBLE TO USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22592093 ↗MalfunctionSep 25, 2023Malposition of Device; Malposition of Device
A PHYSICIAN REPORTED THAT DURING SURGERY, THEY NOTICED THAT A 71 YEAR OLD UNDERWENT A CATARACT SURGERY WITH A COMPANY LENS, AXIS WAS ORIGINALLY 90 BUT IOL ROTATED POSTOP TO 115 WITH VA OF 80. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 17807117 ↗InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
A CONSUMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRY VISION AND RESIDUAL ASTIGMATISM. CANNOT DRIVE AT NIGHT AFTER SURGERY WITH BOTH EYES. XIIDRA WAS PRESCRIBED TO HELP WITH THE STARBURSTS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment
MAUDE report 13693176 ↗InjuryFeb 18, 2022Failure to Align; Device Dislodged or Dislocated; Failure to Align; Device Dislodged or Dislocated
A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AT ALL DISTANCES, AND THE LENS CONTINUES TO SPIN OUT OF PLACE. THE LENS WAS EXCHANGED AFTER FEW DAYS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN COMPLETED.
Patient problems: Blurred Vision
MAUDE report 13559861 ↗InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT FELT HARD TO FOCUS AND VISUAL IMAGES WERE NOT SHARP. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR A DIFFERENT MANUFACTURER¿S MONOFOCAL IOL APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 12340750 ↗
Other Extended depth of focus intraocular lens devices
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens1 recall49 reports
- 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.