AcrySof™ IQ Vivity™ DFT415 (REF DFT415.180)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652422017), received between Feb 24, 2025 and Mar 3, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Opacification” (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
- Material Opacification1
- Product Quality Problem1
Patient problems
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD BEEN FAULTY AND COULD NOT BE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24496305 ↗InjuryFeb 24, 2025Material Opacification; Material Opacification
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, COMPANY IOL WAS IMPLANTED IN BOTH EYES. POST-OPERATIVE UNCORRECTED VISUAL ACUITY WAS RECORDED AS 0.9 IN THE RIGHT EYE AND 0.8 IN THE LEFT EYE. PATIENT WAS EXPERIENCING IMPAIRED VISION IN THE LEFT EYE, DESCRIBING A DISTINCT CLOUDING THAT IMPROVES SLIGHTLY WHEN LOOKING PAST IT, CAUSING A TILTED HEAD POSITION. THE RIGHT EYE REMAINS UNAFFECTED. UPON CONDUCTING A SLIT LAMP EXAMINATION, THE SURGEON OBSERVED A VERTICAL, EXTENSIVE CLOUDING ON THE LENS OF THE LEFT EYE, APPROXIMATELY 1.5 MM WIDE AND 5 MM LONG, LIKELY ON THE FRONT OF THE IOL. LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 21447560 ↗
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- 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.