AcrySof™ IQ Vivity™ DFT315 (REF DFT315.220)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
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652421683), received between Jul 27, 2021 and Nov 8, 2024 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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 Problem3
- Appropriate Device Problem Term/Code Not Available1
- Scratched Material1
Patient problems
- Blurred Vision3
- Visual Impairment2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRY VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 12 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MISSED BY 1.5 DIOPTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 20642616 ↗MalfunctionMay 27, 2024Scratched Material; Scratched Material
A NURSE REPORTED ABOUT A SCRATCH ON LENS. THE SURGERY WAS COMPLETED WITH STANDBY LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19400276 ↗InjuryNov 24, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED THAT LENS DID NOT WORK. THE CLINICAL REASON WAS INCORRECT POWER/AXIS. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS WITHIN 3 MONTHS AFTER INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12870829 ↗InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED ¿BLURRED VISION¿. THE IOL WAS EXPLANTED APPROXIMATELY 3 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON GIVEN FOR THE EXPLANT WAS ¿ANISOMETROPIA¿. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 12771889 ↗InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT THE POWER OF 22 D LENS WAS REPLACED WITH POWER OF 21 D LENS.
Patient problems: Blurred Vision
MAUDE report 12234041 ↗
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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.