AcrySof™ IQ Vivity™ DFT315 (REF DFT315.195)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
- 7
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652421638), received between Jul 15, 2021 and Sep 15, 2025 — classified as 5 injuries, 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
- Adverse Event Without Identified Device or Use Problem4
- Crack1
- Device Dislodged or Dislocated1
- Scratched Material1
Patient problems
- Blurred Vision2
- Insufficient Information2
- Visual Impairment2
- Eye Irritation1
- Macular Edema1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED, AND FILE WAS REASSESSED AS IT WAS NOTED THAT THE MACULAR EDEMA HAD NOTHING TO DO WITH THE IOL. IT WAS A CASE OF AGE-RELATED MACULAR DEGENERATION. IT HAS BEEN DETERMINED THAT THERE IS NO REPORTED COMPLAINT OR DEFECT WITH THE PRODUCT.
Patient problems: Macular Edema
MAUDE report 23050582 ↗MalfunctionJul 1, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS SCRATCHED. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND REPLACED WITH SAME DIOPTER UNSPECIFIED LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22370329 ↗InjuryApr 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED CONTINUED DISCOMFORT. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE LENS WAS EXCHANGE DUE TO THE DISLOCATION OF THE LENS.
Patient problems: Eye Irritation; Insufficient Information
MAUDE report 21900284 ↗InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS BLURRY VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 16477352 ↗MalfunctionMay 4, 2022Crack; Crack
A HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION A CRACK ON THE SIDE OF THE OPTIC WAS NOTICED POSITIONED 90DEGREES AWAY FROM THE OPTIC HAPTIC JUNCTION. AS CRACK WAS IN PERIPHERY THE LENS REMAIN IN EYE AS NOT AFFECTING VISUAL AXIS. LENS FORCEPS FOR LOADING CAME INTO CONTACT WITH THE LENS AT OPTIC HAPTIC JUNCTION BUT NOT WHERE CRACK IN OPTIC WAS NOTICED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14277468 ↗InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRY VISION AND RESIDUAL ASTIGMATISM. CANNOT DRIVE AT NIGHT AFTER SURGERY WITH BOTH EYES. XIIDRA WAS PRESCRIBED TO HELP WITH THE STARBURSTS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 13692901 ↗InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED AN EXPLANTED INTRAOCULAR LENS WITH A PATIENT REASON FOR EXPLANT OF, UNABLE TO ACHIEVE CLEAR VISION AT ANY DISTANCE AND A CLINICAL REASON FOR EXPLANT OF, BCVA 20/30. ADDITIONAL FOLLOW UP REQUESTED.
Patient problems: Visual Impairment
MAUDE report 12176953 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.