Skip to content

AcrySof™ IQ Vivity™ DFT315 (REF DFT315.245)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
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652421737), received between Apr 13, 2021 and Aug 31, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 Problem1
  • Insufficient Device Problem Information1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Blurred Vision1
  • Discomfort1
  • Visual Impairment1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT HAD EXPERIENCED DISCOMFORT, BLURRED VISION AND REDUCED CLARITY DUE TO INTRAOCULAR LENS WHICH WERE IMPLANTED, HAD SIGNIFICANTLY IMPACTED THE QUALITY OF LIFE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Blurred Vision; Discomfort

    MAUDE report 17661351 ↗
  • InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A CUSTOMER REPORTED, DECREASED VISION FOLLOWING INTRAOCULAR LENS IMPLANT. THE FUNCTION OF THE EYE APPEARS TO BE GOOD BUT THE VISION LAGS BEHIND. THE PATIENT IS REPORTED TO HAVE DRY EYE FROM THE BEGINNING AND VISIBILITY DECREASES DURING THE DAY. WITH CORRECTION THE EYE SEES WELL TO READ BUT THE DISTANT VISION CANNOT BE IMPROVED. A LENS EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS APPROXIMATELY 5.5 MONTHS FOLLOWING THE INITIAL SURGERY.

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

    MAUDE report 11660817 ↗

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.