AcrySof™ IQ Vivity™ DFT015 (REF DFT015.250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652421331), received between Sep 30, 2021 and Mar 6, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PERSISTENT SYMPTOMS CONTINUED TO SIGNIFICANTLY IMPACT DAILY FUNCTIONING, AS WELL AS ABILITY TO WORK. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Visual Disturbances

  MAUDE report 24528200 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  Additional information was received via the health authority that the patient experienced severe, unresolved visual impairment, including persistent peripheral blockage/negative dysphotopsia and permanent obstruction/shadowing in the left eye.

  Patient problems: Dry Eye(s); Visual Disturbances; Visual Impairment

  MAUDE report 23976898 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED WITH A DESCRIPTION OF CAPSULAR RETRACTION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Contracture

  MAUDE report 21774594 ↗
• MalfunctionMar 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OPTIC RUPTURE WAS OBSERVED AFTER BEING INSERTED IN CARTRIDGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21535017 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT A PATIENT WHO HAD LENS IMPLANTED ON HER FIRST EYE ON (B)(6) 2023. HE INDICATES THAT THE PATIENT REPORTS VISUAL DISCOMFORT, RESEMBLING AN ARC-SHAPED BLACK SCOTOMA ON THE TEMPORAL SIDE OF HER PARACENTRAL VISUAL FIELD. UNCORRECTED ACUITY WAS GOOD AT 12/10 (DISTANCE VISION), P4 (NEAR VISION). THE SURGEON PLANS TO SEE THE PATIENT AGAIN IN 15 DAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 18149118 ↗
• InjurySep 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT HAD EXPERIENCED DISCOMFORT, BLURRED VISION AND REDUCED CLARITY DUE TO INTRAOCULAR LENS WHICH WERE IMPLANTED, HAD SIGNIFICANTLY IMPACTED THE QUALITY OF LIFE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Discomfort

  MAUDE report 17676177 ↗
• InjuryDec 15, 2021Adverse 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 (IOL) IMPLANTATION THE PATIENT WAS NOT HAPPY WITH CLARITY. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS WITHIN 5 MONTHS AFTER INITIAL IMPLANTATION IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13008507 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE REFRACTION WAS -1 SPHERICAL AND VISUAL ACUITY SC WAS 0.2. PHOTOREFRACTIVE KERATECTOMY WAS PERFORMED. THE PATIENT RESULTED WITH 1 DIOPTER IN MYOPIA. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Visual Impairment

  MAUDE report 12907140 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS DISSATISFIED WITH DISTANCE VISION DESPITE HAVING GOOD REFRACTION. PATIENT ALSO HAD A DRY EYE. ADDITIONAL INFORMATION WAS PROVIDED THAT POST IMPLANTATION, THE NIGHT VISION WAS DIFFICULT AND THE VISION WAS STILL BLURRY OVERALL. THE CLINICAL FINDINGS STATED THAT THERE WAS A POOR TEAR FILM, PATIENT WAS SEEING HALOS. NSAIDS AND DRY EYE MEDICINE WAS PRESCRIBED TO THE PATIENT. THE PATIENT WAS ALSO TREATED WITH REXON ON (B)(6) 2021, THE CLINICAL FINDING STATED THAT THE PATIENT WAS ADAPTING TO WITH TIME. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Disturbances; Visual Impairment

  MAUDE report 12558214 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS DISSATISFIED WITH DISTANCE VISION DESPITE HAVING GOOD REFRACTION. PATIENT ALSO HAD A DRY EYE. ADDITIONAL INFORMATION WAS PROVIDED THAT POST IMPLANTATION THE NIGHT VISION WAS DIFFICULT AND THE VISION WAS STILL BLURRY OVERALL. THE CLINICAL FINDINGS STATED THAT THERE WAS A POOR TEAR FILM, PATIENT WAS SEEING HALOS. NSAIDS AND DRY EYE MEDICINE WAS PRESCRIBED TO THE PATIENT. THE PATIENT WAS ALSO TREATED WITH A DEVICE FOR DRY EYES, THE CLINICAL FINDING STATED THAT THE PATIENT WAS ADAPTING TO WITH TIME. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Disturbances; Visual Impairment

  MAUDE report 12557837 ↗