AcrySof™ IQ Vivity™ DFT015 (REF DFT015.100)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652421034), received between Jul 18, 2024 and Mar 16, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Defective Device1
- Scratched Material1
Patient problems
- Insufficient Information2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2026Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY IT WAS NOTICED THAT HAPTICS WAS SCRATCHED AND UNUSABLE. SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24604093 ↗MalfunctionJul 24, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS DEFECTIVE. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19815193 ↗InjuryJul 18, 2024Crack; Crack
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INSERTING LENS INTO THE EYE, IT WAS NOTED THAT THE LENS CAME OUT OF CARTRIDGE WITH PERICENTRAL CRACK. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. PATIENT HAD TINY BLEED INTO ANTERIOR CHAMBER UPON LENS REMOVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19769951 ↗
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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.