AcrySof™ IQ Vivity™ DAT015 (REF DAT015.190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652424615), received between Jul 23, 2021 and Nov 11, 2024 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2024Defective Component; Defective Component

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING LOADED THE HAPTIC GOT STUCK. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649815 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE IOL (INTRAOCULAR LENS) WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. PATIENT REASON AND CLINICAL REASON FOR EXPLANT WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20568886 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT HAD INCREASED HALOS AND GLARE. EVEN AFTER EXCHANGE WITH NON-COMPANY MULTIFOCAL LENS, PATIENT'S CONDITION WAS NOT RESOLVED, THE VISION WAS STILL BLURRY AND THERE WAS POSSIBILITY OF ASTIGMATISM.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 16724296 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT COMPLAINTS UNCORRECTED ACUITY VERY BLURRY FOR DISTANCE, EXCESSIVE MYOPIA IN POST LASIK EYE. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15913991 ↗
• InjuryNov 5, 2022Adverse 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 EXPERIENCED BLURRED VISION-MILD TOPOGRAPHIC ABNORMALITY. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15740864 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIRECTOR OF NURSING REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AND REFRACTIVE ERROR. THE IOL WAS EXCHANGED FOR ANOTHER MONOFOCAL LENS WITHIN 1 MONTH FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT WAS UNABLE TO CLEAR AT ANY DISTANCE AFTER SURGERY AND UNABLE TO ADOPT. THE PATIENT'S TARGET WAS CHANGED TO -1.75 AND THE LENS WAS EXPLANTED AND REPLACED WITH NON COMPANY MONOFOCAL LENS.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15699215 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT WAS FRUSTRATED WITH THE QUALITY OF THE VISION AND FELT HIS VISION WAS WORSE THAN PREOPERATIVE. HENCE IT WAS DECIDED TO EXPLANT THE LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS INTOLERANCE TO THE LENS AND PATIENT DISSATISFACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED AND IT WAS FURTHER CLARIFIED INTOLERANCE TO LENS AS GENERALIZED BLUR AND HALOS WITH POOR OVERALL QUALITY OF VISION AND UNABLE TO DRIVE ESPECIALLY AT NIGHT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 14455764 ↗
• InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCE. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 14410405 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH THE VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER, WHO REPORTED THAT THERE WAS NO PATIENT HARM INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 13088186 ↗
• MalfunctionNov 3, 2021Defective Device; Defective Device

  A NON-HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SURGEON IMPLANTED LENS AND NOTED DEFECT ON LENS. THE SURGEON REMOVED THE LENS AND REPLACED WITH SAME MODEL AND DIOPTER LENS. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745485 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED DOUBLE VISION FOLLOWING INTRAOCULAR LENS IMPLANTATION PROCEDURES OF BOTH EYES. IT WAS NOTED THAT DOUBLE VISION AT READING AND COMPUTER DISTANCE; "ONE IMAGE RELATIVELY CLEAR, AND ANOTHER LIGHTER IMAGE OVERLAPPING AND SLIGHTLY OFFSET, MAKING IT IMPOSSIBLE TO DISCERN WHAT IS WRITTEN. DISTANCE IS EFFECTED AS WELL BUT LESS IMPACTFUL - MARGINAL." ADDITIONAL INFORMATION REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12218863 ↗