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AcrySof™ IQ Vivity™ DAT015 (REF DAT015.140)Recalls & reported problems

Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant

Adverse event reports
4
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652424516), received between Mar 31, 2022 and Aug 21, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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
  • Crack1

Patient problems

  • Visual Impairment3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Blurred Vision1
  • Corneal Edema1
  • Visual Disturbances1

Recent adverse event reports

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

  • InjuryAug 21, 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'S CLARITY AND NIGHT VISION WAS INSUFFICIENT. THE IOL WAS EXCHANGED FOR ANOTHER MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS POOR NEUROADAPTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM.

    Patient problems: Blurred Vision; Visual Impairment

    MAUDE report 17584670 ↗
  • InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT NEAR VISION WAS NOT AS GOOD AS EXPECTED, YAG LASER, GROWTH ON THE LENSES. ADDITIONAL INFORMATION WAS REQUESTED.

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

    MAUDE report 16770501 ↗
  • MalfunctionAug 25, 2022Crack; Crack

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE NOTICED A SMALL CRACK ON THE OPTIC AND DID NOT INSERT IT. THERE WAS A PATIENT CONTACT. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS PATIENT HARM OF INCREASED CORNEA EDEMA REPORTED. THE PATIENT WAS HEALING WELL AND WAS HAPPY. THE PHYSICIAN'S PROGNOSIS WAS OPTIMISTIC.

    Patient problems: Corneal Edema

    MAUDE report 15291515 ↗
  • InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCE, GHOSTING/SHADOWS. THE PATIENT ALSO HAD RESIDUAL ASTIGMATISM. THE PATIENT UNHAPPY WITH OUTCOME TARGET. THERE WAS NO PATIENT HARM. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL IN A SECONDARY PROCEDURE.

    Patient problems: Visual Disturbances; Visual Impairment

    MAUDE report 13963397 ↗

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.