AcrySof™ IQ Vivity™ DFT415 (REF DFT415.190)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
- 7
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652422031), received between Nov 4, 2021 and May 8, 2026 — classified as 4 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Eject” (2 reports).
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 Problem3
- Failure to Eject2
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
Patient problems
- Blurred Vision2
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Visual Impairment2
- Headache1
- Visual Disturbances1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT DUE TO THE RESIDUAL ASTIGMATISM AND PATIENT INTOLERANCE, THE PATIENT EXPERIENCED HEADACHES AND WAS NOT ACHIEVING GOOD VISUAL ACUITY. AS A RESULT, THE LENS WAS EXCHANGED TO MONOFOCAL IOL WAS EXCHANGED FOR THE DIFFERENT LENS MODEL WITH SAME DIOPTER POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.
Patient problems: Headache; Insufficient Information; Visual Impairment
MAUDE report 25124138 ↗MalfunctionDec 5, 2023Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED., RECEIVED AND STATED THE INCIDENT OCCURRED DURING SURGERY, DURING THE INJECTION, WHILE THE IOL WAS PROGRESSING IN THE DELIVERY SYSTEM/DURING PLACEMENT IN THE EYE. AFTER CHANGING THE IMPLANT AND THE CARTRIDGE, THE SURGERY WAS COMPLETED, AN IOL OF SAME DIOPTER HAS BEEN IMPLANTED AND NO PATIENT HARM HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18266989 ↗MalfunctionJan 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PHYSICIAN REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS DECENTERED SUPERIORLY. THE PATIENT WAS COMPLAINING OF REDUCED VISUAL ACUITY AND UNABLE TO IMPROVE ON REFRACTION.
Patient problems: Blurred Vision
MAUDE report 16204329 ↗InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE EXPERIENCED INADEQUATE READING POWER. THE LENS WAS LATER EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 14112432 ↗InjuryApr 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION, THE PATIENT WAS UNHAPPY WITH THE LENS HENCE THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14052424 ↗MalfunctionNov 10, 2021Failure to Eject; Failure to Eject
A CONSUMER REPORTED VIA IOL REPLY CARD THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE OVERSHOT INJECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12789647 ↗InjuryNov 4, 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 EXPERIENCED BLURRED VISION DUE TO IOL POWER. THE IOL WAS EXCHANGED WITH ANOTHER IOL MODEL, 42 DAYS AFTER FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Blurred Vision
MAUDE report 12751940 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.