AcrySof™ IQ Vivity™ DFT015 (REF DFT015.275)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652421386), received between Jan 13, 2023 and Apr 16, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Dent in Material1
- Failure to Advance1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Dent in Material
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF LENS DAMAGED ON STRIPED OPTICS. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE LENS WAS EXPLANTED DURING THE INITIAL PROCEDURE AND THE PATIENT CURRENT CONDITION WAS RECOVERED.
Patient problems: Insufficient Information
MAUDE report 24903232 ↗MalfunctionMay 27, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS DAMAGE BY HANDPIECE INJECTOR. LENS OPTIC AND HAPTIC WERE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22087858 ↗MalfunctionJan 13, 2023Break; Failure to Advance; Break; Failure to Advance
A NURSE REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS GOT TRAPPED INSIDE THE CARTRIDGE. IT WAS REMOVED TO HAVE A BETTER VISUALIZATION, SHE REALIZES THAT THE LENS HAS BROKEN. THE SURGERY WAS COMPLETED BY REPLACING WITH ANOTHER IOL ON THE SAME DAY. THERE WAS PATIENT CONTACT WITH THE PRODUCT HOWEVER NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16156115 ↗
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens75 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.