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AcrySof™ IQ Vivity™ DFT415 (REF DFT415.215)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
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652422086), received between Mar 17, 2021 and Jul 15, 2022 — classified as 4 injuries.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem3
  • Appropriate Device Problem Term/Code Not Available1
  • Device Dislodged or Dislocated1
  • Scratched Material1

Patient problems

  • Visual Impairment3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Blurred Vision1
  • Visual Disturbances1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISUAL ACUITY, FLIPPED AXIS . THE IOL WAS SCHEDULED TO BE EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE.

    Patient problems: Visual Impairment

    MAUDE report 15031435 ↗
  • InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED BLURRY VISION HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL COMPLICATION OF THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Blurred Vision

    MAUDE report 13391108 ↗
  • InjuryDec 2, 2021Device Dislodged or Dislocated; Scratched Material; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Scratched Material; Appropriate Device Problem Term/Code Not Available

    AN OTHER HEALTH PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GAVE RISE REFRACTIVE SURPRISE OF -2.00. THE IOL WAS EXCHANGED BECAUSE THE PATIENT WAS INTOLERANT OF MONOVISION APPROXIMATE 1 MONTH AFTER THE INITIAL PROCEDURE. DURING THE EXPLANT PROCEDURE (OPERATIVE DIAGNOSIS), LENS DISLOCATION AND SCRATCH ON LENS WERE IDENTIFIED. THE PHYSICIAN ALSO STATED THAT THE LEFT EYE CORNEA WAS QUITE ABERRATED FROM MULTIPLE LASER TREATMENTS AND THAT WAS INTERACTING NEGATIVELY WITH THE IOL.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances; Visual Impairment

    MAUDE report 12919819 ↗
  • InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AN OPHTHALMIC SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD REDUCED VISION (BCVA). THE IOL WAS EXPLANTED 4 MONTHS FOLLOWING THE INITIAL PROCEDURE.

    Patient problems: Visual Impairment

    MAUDE report 11508928 ↗

Other Extended depth of focus intraocular lens devices

All Extended depth of focus intraocular lens devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.