AcrySof™ IQ Vivity™ DFT315 (REF DFT315.200)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
- 8
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652421645), received between Aug 8, 2022 and Dec 12, 2025 — classified as 5 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 Problem4
- Device Contamination with Chemical or Other Material1
- Device Dislodged or Dislocated1
- Particulates1
- Scratched Material1
Patient problems
- Insufficient Information3
- Visual Impairment2
- Blurred Vision1
- Halo1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT REPORTED OF LENS POWER CHANGE. THE LENS WERE EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 23788625 ↗InjurySep 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER TWO WEEKS LENS WAS DISLOCATED. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. THERE WAS NO FURTHER IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23092733 ↗InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRA-OCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE, HALOS AND POOR DEPTH PERCEPTION.THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Halo; Visual Disturbances
MAUDE report 18977103 ↗MalfunctionSep 15, 2023Particulates; Particulates
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE AND THERE IS NO ISSUES RELATED TO VISION OR OTHER CONDITIONS.
Patient problems: Insufficient Information
MAUDE report 17753865 ↗InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MULTIFOCAL INTOLERANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 17296596 ↗MalfunctionApr 28, 2023Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAS SCRATCHES AND IT WAS REMAINED IN THE EYE. ADDITIONAL INFORMATION WAS RECEIVED STATING THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16829068 ↗MalfunctionOct 14, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AN OPHTHALMIC NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTED A WHITE FILAMENT IN PARACENTESIS AND IT WAS REMOVED WITH FORCEPS AND THE SURGERY WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15603189 ↗InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PURCHASING OFFICER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE INTRAOCULAR LENS WAS EXCHANGED WITH A MONOFOCAL LENS IN SECONDARY PROCEDURE IN A MONTH. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 15183035 ↗
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- 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.