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AcrySof™ IQ Vivity™ DFT515 (REF DFT515.190)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
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 00380652422444), received between Mar 17, 2021 and Aug 16, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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
  • Defective Device1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Blurred Vision1
  • Glaucoma1
  • Inflammation1
  • No Clinical Signs, Symptoms or Conditions1
  • Visual Impairment1

Recent adverse event reports

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

  • InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AN OPHTHALMIC SURGEON REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT COMPLAINED OF EXPERIENCING CENTRAL SCOTOMA (CENTRAL VISION LOSS), BUT ONCE THE LIGHTS WERE TURNED ON, EVERYTHING WENT BACK TO NORMAL, PATIENT COULD SEE EVERYTHING. THE PATIENT WAS SEEING BLACK CIRCLES IN FRONT OF THE VISUAL FIELD UPON AWAKENING FROM SLEEP FROM THE PAST 2 WEEKS. THE SURGEON TOLD THAT THE LENS WAS PERFECTLY CENTERED, VISION WAS GOOD INITIALLY AFTER CATARACT SURGERY WAS DONE. THE INTRAOCULAR LENS (IOL) HAD NO DEFECT OR DAMAGE. YTTRIUM-ALUMINUM-GARNET (YAG) LASER WAS DONE TO CLEAR ANY LEVEL OF POSTERIOR CAPSULE OPACITY (PCO). THE PATIENT HAD NONEXUDATIVE AGE-RELATED MACULAR DEGENERATION (ARMD) (EARLY DRY STAGE), YET EXAMINATION IMAGES SHOWED THAT IT WAS NOT ADVANCED AND ALL THE SURGEONS WHO HAD CHECKED THE CASE SAID THAT ARMD IS NOT THE CAUSE FOR THE SCOTOMA. THE CLINICAL EXAMINATION DONE AFTER IMPLANTATION ALSO REVEALED THAT THE PATIENT HAD TOXIC MACULOPATHY, GLAUCOMA SECONDARY TO EYE INFLAMMATION (INDETERMINATE STAGE). ADDITIONAL INFORMATION RECEIVED STATED THAT THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. T

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

    MAUDE report 17554705 ↗
  • MalfunctionNov 19, 2021Defective Device; Defective Device

    A HEALTHCARE PROFESSIONAL REPORTED THAT, THE OPTIC WAS FOUND TO BE DEFECTIVE. PATIENT IMPACT INITIALLY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12842819 ↗
  • InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A HEALTH PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PATIENT EXPERIENCED BLURRED VISION AND UNDER CORRECTED ASTIGMATISM. THE LENS WAS EXCHANGED FOR A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

    MAUDE report 11504700 ↗

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.