AcrySof™ IQ Vivity™ DFT315 (REF DFT315.125)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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652421492), received between Aug 11, 2022 and Aug 8, 2025 — classified as 3 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Product Quality Problem1
Patient problems
- Visual Disturbances2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Insufficient Information1
- Ptosis1
- Red Eye(s)1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2025Product Quality Problem; Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS DUE TO PROBLEMS WITH THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22748557 ↗InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED THE EYE INFECTIONS, RED EYE, DROPPING EYES AND GLARES. THE CURRENT REGIME OF MEDICATION WAS HELPING BUT CONSUMER WAS TOLD THAT VISION FOR READING AND COMPUTER WORK MAY NEED GLASSES. ADDITIONAL INFORMATION WAS RECEIVED STATING THE CONSUMER FEELS LIKE SHE HAS CATARACTS AGAIN AND HER NEAR VISION FOR READING APPEARS TO BE WORSE THAN BEFORE SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Ptosis; Red Eye(s); Unspecified Infection; Visual Disturbances
MAUDE report 15429925 ↗InjuryAug 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE EXPLANT DUE TO PATIENT REASON FOR EXPLANT OF DOUBLE VISION, CLINICAL REASON FOR EXPLANT OF DYSPHOTOPSIA AND LENS DECENTRATION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 15210546 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.