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AcrySof™ IQ Vivity™ DFT015 (REF DFT015.170)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
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652421171), received between Nov 10, 2021 and Sep 23, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched 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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Scratched Material1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Halo1
  • No Clinical Signs, Symptoms or Conditions1
  • Uveitis1
  • Visual Disturbances1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SEES THE HEADLIGHTS OF THE CAR IN A LONGITUDINAL OVAL SHAPE AND THREE MORE SHADOWS AROUND IT, THE FIRST ONE IS BLACK, OUTSIDE OF IT IS RED, AND THEN WHITE. THE SURGERY WENT WITHOUT COMPLICATIONS, THE PSEUDOPHAKIA IS NORMAL, THE MACULAR OCT (OPTICAL COHERENCE TOMOGRAPHY) WAS REPEATED POSTOPERATIVELY AND THE FINDINGS WAS NORMAL. IN THE FIRST POSTOPERATIVE MONTH, THE PATIENT HAD POSTOPERATIVE CENTRAL SEROUS CHORIORETINOPATHY ON HER RIGHT EYE, WHICH WAS COMPLETELY CURED BY LOCAL CORTICOSTEROID THERAPY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Patient problems: Uveitis; Visual Disturbances

    MAUDE report 15474757 ↗
  • InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CONSUMER EXPERIENCED HALOS AROUND LIGHT DURING DAY AND NIGHT. BUT FOLLOWING POSTERIOR CAPSULAR OPACIFICATION, THE HALOS DISAPPEARED 80% DURING THE DAY AND 50% AT NIGHT. THE SYMPTOMS STARTED 2 MONTHS AFTER SURGERY. THE SURGEON WAS PRESCRIBED WITH PILOCARPINE TO DECREASE THE SYMPTOMS. NO FURTHER INFORMATION AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

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

    MAUDE report 15250724 ↗
  • MalfunctionNov 10, 2021Scratched Material; Scratched Material

    A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS FOUND ON THE OPTIC AFTER IMPLANTATION. THE IOL WAS EXCHANGED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12785821 ↗

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.