AcrySof™ IQ Vivity™ DFT015 (REF DFT015.260)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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652421355), received between Nov 12, 2021 and Dec 7, 2024 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 Problem2
- Break1
- Failure to Advance1
- Scratched Material1
Patient problems
- Blurred Vision2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Eye Injury1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 7, 2024Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE MARKS ON THE IMPLANT. THE IMPLANT WAS LOADED INTO THE CARTRIDGE UNDER THE MICROSCOPE USING A MONOFILAMENT PLIERS. THERE WERE NO MARKS PRIOR TO LOADING. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20873450 ↗InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT UNABLE TO SEE DISTANCE. THE LENS WAS REMOVED IN A SECONDARY PROCEDURE.
Patient problems: Blurred Vision
MAUDE report 15104624 ↗InjuryJul 22, 2022Break; Failure to Advance; Break; Failure to Advance
A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS SEEMED STUCK DURING PLACEMENT OF THE LENS, HAPTIC HAS BROKEN OFF. LENS HAS BEEN CUT IN HALF FOR REMOVAL AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE WOUND WAS ENLARGED WHILE REMOVING THE LENS AND SUTURE WAS DONE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury
MAUDE report 15084287 ↗InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION THE LENS WAS EXCHANGED FOR A DIFFERENT LENS 1 MONTH AFTER INITIAL IMPLANTATION IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 12802162 ↗
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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.