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AcrySof™ IQ Vivity™ DAT415 (REF DAT415.235)Recalls & reported problems

Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · Class 3 · Implant

All models of AcrySof IQ Vivity (225)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652427982), received between Mar 14, 2022 and Sep 18, 2022 — classified as 2 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Blurred Vision2
  • Excessive Tear Production1
  • Eye Pain1
  • Irritability1
  • Visual Disturbances1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRY FUZZY EDGES. THE PATIENT CANNOT READ A TV SCREEN. EVEN LARGE SCREEN TVS HAVE LIKE THE WEATHER REPORT EVEN 8 TO 10 FOOT AWAY. EVERYTHING HAS A SLIGHT SHADOW JUST ABOVE IT. . LETTERS HAVE A GHOST SHADOW JUST ABOVE THEM. THE BIGGEST PROBLEM THE PATIENT FACING IS THE DYSPHOTOPSIA. ALL LIGHTS ESPECIALLY IN THE DISTANCE, GREATER THAN READING DISTANCE, HAVE STARBURSTS, GLARE, BRILLIANCE, SPARKLE, ETC, HENCE CAN'T READ INFO FROM LIGHT. ADDITIONAL INFORMATION RECEIVED AND STATED FROM THE BEGINNING EVERYTHING IS STILL BLURRY AND OUT OF FOCUS. THE EDGES OF ANYTHING ARE NOT SHARP AND THE CONTRAST IS POOR. EYES ARE VERY OFTEN SORE, BURNING AND STINGING, SOMETIME SCRATCHY FEELING. ONE EVENING AFTER WORKING IN SHOP REALLY STRAINING TO SEE, VISION JUST WENT GREY SHADOWY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Excessive Tear Production; Eye Pain; Irritability; Visual Disturbances

    MAUDE report 15443379 ↗
  • InjuryMar 14, 2022Adverse 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 EXPERIENCED BLURRY VISION AND THERE WAS NO IMPROVEMENT WITH REFRACTION. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS CORNEAL ENDOTHELIUM AND EPITHELIUM IRREGULARITY. THE IOL WAS EXCHANGED WITH AN ALTERNATE NO COMPANY IOL IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT VISION COULD NOT IMPROVE WITH REFRACTION ON RIGID GAS PERMEABLE (RGP)OVER REFRACTION AFTER OCULAR SURFACE REHABILITATION FOR SEVERAL MONTHS WITH PRESERVATIVE FREE TEARS PUNTAL PLUGS.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

    MAUDE report 13758962 ↗

Other Extended depth of focus intraocular lens devices

All Extended depth of focus intraocular lens devices →

Sources and updates

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