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AcrySof™ IQ Vivity™ DAT315 (REF DAT315.190)Recalls & reported problems

Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · 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 00380652427074), received between Nov 15, 2021 and Apr 27, 2023 — classified as 3 injuries, 1 malfunction.

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 Problem2
  • Device Dislodged or Dislocated1
  • Scratched Material1

Patient problems

  • Blurred Vision3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Dry Eye(s)1
  • Eye Pain1
  • Headache1
  • No Clinical Signs, Symptoms or Conditions1
  • Visual Disturbances1
  • Visual Impairment1

Recent adverse event reports

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

  • InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE DOUBLE IMAGE CHANGES SIDES: TO THE LEFT FOR LIGHT ON DARK, AND TO THE RIGHT FOR DARK ON RIGHT IN THE RIGHT EYE. BASED ON THE INFORMATION RECEIVED IT HAS BEEN CLARIFIED THAT THE PREVIOUSLY REPORTED EVENTS SUCH AS HEAD ACHE, EYE PAIN, USING DROPS, ARE NOT RELATED TO THE COMPANY LENS. THE WRINKLE ON THE EYE AND THE DRY EYE ARE CONSIDERED TO BE PRIOR TO THE SURGERY. HENCE THIS FILE NOW DOES NOT MEET CRITERIA FOR REPORTING HENCE NO FURTHER REPORTS WOULD BE NEEDED. BASED ON CLARIFICATION RECEIVED FOLLOWING SUBMISSION OF THE INITIAL REPORT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS A SERIOUS INJURY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE RIGHT EYE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Eye Pain; Headache; Visual Disturbances

    MAUDE report 16822215 ↗
  • InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS EXPLANTED DUE TO -1.25D MYOPIC OUTCOME, PATIENT HAD BLURRY VISION. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Blurred Vision; Visual Impairment

    MAUDE report 15259261 ↗
  • InjuryMay 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AND SUBLUXATION OF THE LENS. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Blurred Vision

    MAUDE report 14538694 ↗
  • MalfunctionNov 15, 2021Scratched Material; Scratched Material

    A NON HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANTATION SCRATCH WAS NOTICED ON THE LENS. THE IOL WAS REMOVED AND REPLACED ON THE SAME DAY WITH ANOTHER LENS OF THE SAME MODEL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12811471 ↗

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.