AcrySof™ IQ Vivity™ DFT515 (REF DFT515.200)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652422468), received between Mar 11, 2025 and Sep 15, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn2
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TWO LENSES ATTEMPTED TO BE INSERTED, BOTH WERE CRACKED. THERE WAS PATIENT CONTACT REPORTED HOWEVER NO IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY HOWEVER THE PATIENT WAS LEFT APHAKIC, AS NEITHER LENS WAS SUITABLE TO BE INSERTED. THE PATIENT WAS PLANNED TO BE BROUGHT BACK AT A LATER DATE FOR LENS INSERTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23053523 ↗MalfunctionSep 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TWO LENSES ATTEMPTED TO BE INSERTED, BOTH WERE CRACKED. THERE WAS PATIENT CONTACT REPORTED HOWEVER NO IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY HOWEVER THE PATIENT WAS LEFT APHAKIC, AS NEITHER LENS WAS SUITABLE TO BE INSERTED. THE PATIENT WAS PLANNED TO BE BROUGHT BACK AT A LATER DATE FOR LENS INSERTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23053515 ↗MalfunctionMar 11, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DOCTOR IMPLANTED A COMPANY LENS AND ONCE THE LENS WAS IN THE BAG NOTED TWO DIFFERENT MARKS ON THE OPTIC SUPERIORLY. DOCTOR THOUGHT THEY WERE FOREIGN MATERIAL AND TRIED TO REMOVE USING FORCEPS, AND THEN WITH VACUUM BUT THEY COULD NOT BE REMOVED AND SUSPECTED THEY WERE INTRINSIC TO THE LENS. DOCTOR SOMETIMES HAS SEEN SCRATCHES ON THE COMPANY LENS BUT THIS LOOKED DIFFERENT. THE SHAPE OF THE LINE IS UNUSUALLY CURVED.
Patient problems: Insufficient Information
MAUDE report 21573142 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.