AcrySof™ IQ Vivity™ DFT015 (REF DFT015.245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652421324), received between May 17, 2021 and Jul 11, 2025 — classified as 12 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Power Calculation Error” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INJECTING SURGEON REALIZED THE LENS HAD A CRACK. THE SURGERY WAS COMPLETED ON SAME DAY WITH COMPANY ANOTHER LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480842 ↗
• MalfunctionApr 21, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF HAPTIC BROKEN OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21876953 ↗
• 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 LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Contracture

  MAUDE report 21774576 ↗
• InjuryApr 25, 2024Crack; Crack

  A NURSE REPORTED THAT, ON (B)(6) 2023, A COMPANY LENS, WHICH WAS IMPLANTED INTO THE PATIENT'S EYE, WAS FOUND TO HAVE AN IOL CRACK. HOWEVER, IT WAS DETERMINED THAT THE CRACK, BEING OFF-CENTER, WOULD NOT AFFECT THE PATIENT'S VISION, SO THE SURGERY WAS CONCLUDED. HOWEVER, DURING THE POSTOPERATIVE FOLLOW-UP, IT WAS JUDGED THAT THE PATIENT'S VISION WAS AFFECTED, LEADING TO AN EXCHANGE WITH A DIFFERENT DIOPTER BUT SAME MODEL COMPANY LENS ON (B)(6). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 19179817 ↗
• InjuryDec 26, 2023Application Program Problem: Power Calculation Error; Adverse Event Without Identified Device or Use Problem; Application Program Problem: Power Calculation Error; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WAS EXCHANGED FOR A 1.5 DIOPTER MORE OF SAME MODEL COMPANY LENS. THE IOLS THAT WERE EXPLANTED DURING THE EXCHANGE WERE DISCARDED AND THEREFORE NO LONGER AVAILABLE. THE UNDERLYING CAUSE IS ¿IDIOPATHIC¿. THE CALCULATIONS OF THE ORIGINALLY IMPLANTED IOL WERE CARRIED OUT USING ASCRS POST-HYPEROPIC-PRK AND ANTERION POST-LASIK CALCULATION. TAKING INTO ACCOUNT ALL EVENTUALITIES. PATIENT WAS NOW VERY SATISFIED. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AND NO UNSCHEDULED TREATMENT OR MEDICATION WAS NECESSARY. NO HOSPITAL STAY. AS DESCRIBED STATUS AFTER (HYPEROPIC) PRK MANY YEARS AGO, WHICH WAS NOT CARRIED OUT BY US.

  Patient problems: Visual Impairment

  MAUDE report 18391897 ↗
• InjuryDec 22, 2023Application Program Problem: Power Calculation Error; Adverse Event Without Identified Device or Use Problem; Application Program Problem: Power Calculation Error; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WAS EXCHANGED FOR A 1.5 DIOPTER MORE OF SAME MODEL COMPANY LENS. THE IOLS THAT WERE EXPLANTED DURING THE EXCHANGE WERE DISCARDED AND THEREFORE NO LONGER AVAILABLE. THE UNDERLYING CAUSE IS ¿IDEOPATHIC¿. THE CALCULATIONS OF THE ORIGINALLY IMPLANTED IOL WERE CARRIED OUT USING ASCRS POST-HYPEROPIC-PRK AND ANTERION POST-LASIK CALCULATION. TAKING INTO ACCOUNT ALL EVENTUALITIES. PATIENT WAS NOW VERY SATISFIED. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AND NO UNSCHEDULED TREATMENT OR MEDICATION WAS NECESSARY. NO HOSPITAL STAY. AS DESCRIBED STATUS AFTER (HYPEROPIC) PRK MANY YEARS AGO, WHICH WAS NOT CARRIED OUT BY US.

  Patient problems: Visual Impairment

  MAUDE report 18383863 ↗
• InjuryOct 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE NEXT DAY WHEN PATIENT CAME FOR REVIEW THEY NOTICED PROLIFERATION ON THE OPTIC SURFACE OF THE LENS, WHICH IS A FOUND DENSE WHITE PATCHY PRECIPITATE ON THE INFERIOR SURFACE OF THE IOL OF SIZE 1MM*3MM WHICH WAS NOT GETTING WASHED/REMOVED IN SPITE OF REPEATED WASHING. HENCE SURGEON HAD TO EXPLANT THE LENS AND IMPLANTED ANOTHER LENS IN SECONDARY PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17928995 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED. REASON FOR EXPLANT WAS UNKNOWN AT THE TIME. ADDITIONAL INFORMATION INDICATING THAT THE PATIENT'S VISION WAS EXPERIENCING FLUCTUATIONS.

  Patient problems: Visual Disturbances

  MAUDE report 17809294 ↗
• InjuryJun 5, 2023Failure to Align; Failure to Align

  ADDITIONAL INFORMATION WAS RECEIVED, STATING ASTIGMATISM APPEARED IN THE RIGHT EYE, WHICH WAS NOT PRESENT BEFORE IMPLANTATION OF LENS.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 17058555 ↗
• MalfunctionMar 28, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE FAR AND NEAR VISION WAS OF POOR QUALITY AND WAS WORSE THAN BEFORE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE POOR VISION WAS DUE TO DRY EYES AND IS USING LUBRICATING EYE DROPS. IT WAS ADDITIONALLY REPORTED THAT THE EXISTENCE OF VERTICAL BLIND IN THE CORNER OF RIGHT EYE. THIS COULD BE A LENS FOLD. THE REQUESTED TESTS WERE PERFORMED AND THERE IS NOTHING SERIOUS WITH RETINA, JUST NATURAL DEGENERATION DUE TO AGE. 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 Impairment

  MAUDE report 16630115 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15664770 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SECRETARY REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED OBLIQUE REFLEXES IN HER VISION. THE IOL EXCHANGED FOR ANOTHER NON COMPANY LENS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT EXPERIENCED DYSPHOTOPSIA AND ALSO MEDICAL INTERVENTION WAS NECESSARY. THERE WAS REPORTED PATIENT HARM AND INABILITY TO DRIVE AND CARRY OUT DAY-TO-DAY TASKS.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15580593 ↗
• MalfunctionApr 9, 2022Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTH PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT SURGERY, AN IOL WAS DAMAGED BY THE INJECTOR DURING SURGERY. ADDITIONAL INFORMATION RECEIVED AND STATED THERE WAS NO PATIENT IMPACT TO THE PATIENT, THERE WAS A SPARE LENS TO USE. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH LENS INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14065673 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED ENDOPHTHALMITIS. THE PATIENT RECEIVED ANTIBIOTIC TREATMENT. THE PATIENT CONDITION WAS WORSENING AT THE TIME OF REPORTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Endophthalmitis

  MAUDE report 13602853 ↗
• InjuryNov 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT POSTOPERATIVE REFRACTION WAS -0.5 AND VISUAL ACUITY (VA) WAS 0.5. PHOTOREFRACTIVE KERATECTOMY WAS PERFORMED, AFTER THE LASER TOUCH-UP, THE VA WAS 1.0. THE PATIENT IS NOW SATISFIED WITH THIS MONO VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

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

  MAUDE report 12878204 ↗
• MalfunctionOct 29, 2021Scratched Material; Scratched Material

  A REFRACTIVE EQUIPMENT MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS OBSERVED ON THE LENS AT THE CENTRAL. THE IOL WAS REMOVED AND REPLACED WITH A BACKUP LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12717087 ↗
• MalfunctionOct 5, 2021Scratched Material; Scratched Material

  A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, POST IMPLANTATION THE SURGEON NOTICED SCRATCH ON IOL. THE IOL WAS REPLACED ON THE SAME DAY AND THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576232 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH NEAR VISION; BLURRY TO ARM'S LENGTH. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THAT THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL WITH 0.5D DIFFERENCE IN POWER.

  Patient problems: Blurred Vision

  MAUDE report 11831911 ↗