AcrySof™ IQ Vivity™ DFT315 (REF DFT315.240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652421720), received between Jul 12, 2021 and Aug 4, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Device Difficult to Setup or Prepare; Material Twisted/Bent; Device Difficult to Setup or Prepare; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED VIA MHRA INDICATED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE WHEN IMPLANTING THE LENS WAS ¿FLIPPING¿ WHEN IT WAS BEING LOADED INTO THE CARTRIDGE AND WAS NOT HAPPY TO PROCEED WITH THIS LENS. LENS WAS NOT IMPLANTED. THE SPARE LENS WAS USED WITHOUT AN ISSUE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT IT IS UNSURE WHETHER THE HAPTIC WAS INVOLVED OR NOT HOWEVER, IT IS BELIEVED THAT A FOLD IN THE TRAILING HAPTIC WAS PREVENTING THE CARTRIDGE FROM ADVANCING THROUGH THE INTRODUCER. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700592 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AFTER SURGERY THE PATIENT EXPERIENCED DISCOMFORT. SO, THE LENS WAS EXCHANGED IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE PATIENT ONLY EXPERIENCED DISCOMFORT AND NO VISION.

  Patient problems: Visual Impairment

  MAUDE report 21936448 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER BILATERAL IMPLANTATION OF AN INTRAOCULAR LENS (IOL) LENS, 3 WEEKS AFTER THE FIRST EYE AND 2 WEEKS AFTER THE SECOND EYE IN POST-OPERATIVE VISIT, HER VISUAL ACUITY WORSENED AND SHE WAS DIAGNOSED WITH BILATERAL IRVINE GASS MACULAR EDEMA. THE PATIENT'S SECOND EYE WAS STILL UNRESOLVED WITH ACUITY OF 0.7. IN TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2.

  Patient problems: Blurred Vision; Macular Edema

  MAUDE report 19770254 ↗
• MalfunctionJun 5, 2024Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE SURGEON NOTED A MARK ON THE IOL THAT RESEMBLED LINT WITHIN THE LENS. THE LENS REMAINS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 19473304 ↗
• MalfunctionJan 19, 2023Defective Device; Defective Device

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE INJECTOR DID NOT ADVANCE LENS CAUSING A TEAR IN HAPTIC. THE ISSUE HAS BEEN NOTED BEFORE SURGERY. WITH THIS INFORMATION, THE REPORT NO LONGER MEETS REPORTING REQUIREMENT AS THERE NO PATIENT CONTACT WITH THE PRODUCT AND NO PATIENT HARM. NO FURTHER REGULATORY REPORTS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 16205465 ↗
• InjuryNov 28, 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 HAD EXPERIENCED HEADACHE, NAUSEA AND FEELING OFF BALANCED. SYSTEMIC SYMPTOMS VARIED EACH DAY AND NONE ARE ONGOING, SURGEON SAID SHE HAS POSTERIOR CAPSULE OPACIFICATION AND WILL NEED A LASER TO CLEAR THE SCAR TISSUE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING SYMPTOMS HAVE IMPROVED DRAMATICALLY SINCE HAVING PRK. THE IMBALANCE IS GONE AND SHE IS STILL HEALING. THE SYMPTOMS HAVE IMPROVED A LOT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Headache; Nausea

  MAUDE report 15867606 ↗
• MalfunctionJul 22, 2022Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE HAD A DEFECT IN IT THAT APPEARED TO BE A BUBBLE WITHIN THE IOL ITSELF. IT DID NOT APPEAR TO BE ANYTHING THAT COULD'VE HAPPENED DURING THE LOADING PROCESS. LENS WAS CUT INTO PIECES WHILE BEING REMOVED FROM EYE AND THEN DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15084209 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE 24.0 LENS WAS EXCHANGED FOR A 22.5 LENS DUE TO WRONG POWER, MYOPIC AND EXPLANT. THIS DOES NOT MEET CRITERIA FOR REPORTING BASED ON APPLICABLE MEDICAL DEVICE REGULATIONS. A LENS EXCHANGE FROM ONE POWER TO A DIFFERENT POWER IS AN ATTEMPT TO ADJUST OR FINE TUNE THE REFRACTIVE OUTCOME TRYING TO ACHIEVE A DESIRED TARGET WHEN THE INITIAL LENS CALCULATIONS DID NOT ACHIEVE THE INTENDED OUTCOME. THERE IS NO REPORTED DEFECT OR FAULT WITH THE LENS.

  Patient problems: Visual Impairment

  MAUDE report 12148656 ↗