AcrySof™ IQ Vivity™ DFT315 (REF DFT315.170)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652421584), received between Sep 26, 2021 and Sep 20, 2023 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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.
Most reported problems
Device problems
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Material Opacification1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2023Material Opacification; Material Opacification
A PHYSICIAN REPORTED THAT FOLLOWING THE IOL IMPLANTATION PROCEDURE, OBSERVED A NON-CELLULAR LENS FOGGING VISIBLE ON THE IOL WITH DECREASING READING VISION. IT WAS ON THE FRONTSIDE OF THE LENS, LOOKS LIKE A FINGERPRINT (BUT DEFINITELY WAS NOT). ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT EXPERIENCES MORE DIFFICULTY READING.
Patient problems: Blurred Vision
MAUDE report 17779726 ↗InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE NEAR TARGET WAS OFF AND PATIENT WAS DISSATISFIED WITH VISION. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 13892709 ↗MalfunctionFeb 13, 2022Scratched Material; Scratched Material
AN ACCOUNT MANAGER REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS NOTED ON THE IOL. IT WAS UNSURE WHETHER THE SCRATCH WAS CAUSED IN THE LOADING PROCESS, OR IT WAS ALREADY ON THE IOL. THE IOL WAS REMOVED AFTER IMPLANTING & THEY IMPLANTED ANOTHER IOL INSTEAD. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13519364 ↗MalfunctionSep 26, 2021Scratched Material; Scratched Material
A HEALTH PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THERE WAS A VISIBLE MARK/SCRATCH ON POSTERIOR SURFACE OF IOL POST IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12531013 ↗
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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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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