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AcrySof™ IQ Vivity™ DAT015 (REF DAT015.260)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 00380652424752), received between Sep 15, 2022 and Jan 24, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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
  • Failure to Advance1

Patient problems

  • Blurred Vision2
  • Visual Disturbances2
  • Insufficient Information1

Recent adverse event reports

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

  • InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POSITIVE AND NEGATIVE DYSPHOTOPSIA. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE AND EXCHANGED FOR MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Visual Disturbances

    MAUDE report 16231953 ↗
  • InjuryJan 20, 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 PATIENTS VISION IS NOT CLEAR, FUZZY OR HAZY VISION AND VISION SEEMS TO BE GETTING WORSE. THE PATIENT COULD NOT ADOPT TO THE LENS. THE IOL WAS EXCHANGED FOR ANOTHER LENS 7 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT WAS RESOLVED FROM THE SYMPTOMS.

    Patient problems: Blurred Vision

    MAUDE report 16215585 ↗
  • InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A CONSUMER REPORTED FOLLOWING IMPLANTATION OF INTRAOCULAR LENS, THE PATIENT HAD DIFFICULTY, WITH BLURRED DISTANCE VISION WHERE THE PATIENT COULD SEE FROM 2- 8 FEET, BUT THEN THE VISION BLURS, WITH THE BLURRINESS INCREASING AS THE DISTANCE INCREASES. THE PATIENT UNDERWENT YAG LASER PROCEDURE, HOWEVER THE BLURRINESS WAS CONTINUING, ESPECIALLY IN LOW LIGHT AND INDOOR SITUATIONS. THE PATIENT WAS EXPERIENCING FOGGY VISION AROUND SOURCES OF LIGHT AND ALSO EXPERIENCING STARBURSTS AROUND SOURCES OF LIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Blurred Vision; Visual Disturbances

    MAUDE report 15957130 ↗
  • MalfunctionSep 15, 2022Failure to Advance; Failure to Advance

    A NON HEALTH CARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS DID NOT ADVANCE IN THE CARTRIDGE. PATIENT CONTACT WAS OBSERVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 15430820 ↗

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.