AcrySof™ IQ Vivity™ DFT015 (REF DFT015.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00380652421256), received between Apr 15, 2021 and Jan 30, 2026 — classified as 17 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (8 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Product Quality Problem; Device Damaged by Another Device; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, IT WAS OBSERVED THAT THE LENS WAS FAULTY AND COULD NOT BE USED. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DESPITE THE IOL BEING LOADED IN THE USUAL MANNER, THE LENS BECOME CRUMPLED AND ADVANCED FORWARD, MAKING IMPLANTATION IMPOSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222923 ↗
• MalfunctionNov 3, 2025Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; WHILE IMPLANTING THE IOL, THE SURGEON NOTICED A SCRATCH ON THE OPTIC. THE DOCTOR FINISHED THE PROCEDURE ON THE SAME DAY WITHOUT USING REPLACEMENT LENS WITHOUT ANY HARM TO THE PATIENT AND WAITING FOR THE POST OPERATIVE CHECK UP IN ORDER TO SEE IF THERE WAS ANY VISUAL DISCREPANCY. LENS REMAINED IMPLANTED. PATIENT HAD A GOOD OUTCOME AND NO SIDE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450069 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND CONFIRMED THAT THE PATIENT WAS NOT HAPPY WITH HER LENS DESPITE THE OBJECTIVELY VERY GOOD OUTCOME. EVEN AFTER SEVERAL MONTHS, THE PATIENT CONTINUED TO COMPLAIN OF SEVERE GLARE AND DYSPHOTOPSIA. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE DUE TO SEVERE GLARE AND DYSPHOTOPSIA THERE WAS NO FURTHER IMPACT TO THE PATIENT. THE PATIENT SYMPTOMS WERE RESOLVED AFTER THE LENS EXCHANGE. THE PATIENT WAS NOT HOSPITALIZED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Insufficient Information; Visual Disturbances

  MAUDE report 23035792 ↗
• MalfunctionAug 8, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF IOL COULD NOT BE MOVED IN THE SHOOTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22750100 ↗
• MalfunctionFeb 4, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF BROKEN HAPTIC. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303388 ↗
• MalfunctionJan 15, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC DEFORMED OR ASYMMETRIC AND LENS UNDER THE MICROSCOPE IDENTIFIED AS DAMAGED HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157026 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED HALOS AND STREAKS AT NIGHT, FUZZY VISION IN LOW LIGHT AND LESS THAN PERFECT VISION IN RIGHT EYE. THESE ISSUES WERE NOTED FROM THE BEGINNING. INITIALLY, THE HALOS AND STREAK MADE IT IMPOSSIBLE FOR THE PATIENT TO DRIVE AT NIGHT BUT NOW SHE CAN DRIVE BUT WITH SOME DIFFICULTY. THE SURGEON PRESCRIBED GLASSES FOR THE PATIENT, HOWEVER IT DID NOT EFFECTIVELY ADDRESS ANY OF THE ISSUES. THE GLASSES INDEED HELPED WITH THE CLOSE UP VISION AS THEY ARE BI-FOCAL. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE IS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21035035 ↗
• MalfunctionJun 13, 2024Failure to Eject; Failure to Eject

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL STUCK IN CARTRIDGE AND LENS COULD NOT BE INSERTED DESPITE MULTIPLE ATTEMPTS.

  Patient problems: Insufficient Information

  MAUDE report 19528607 ↗
• MalfunctionApr 5, 2024Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN SURGEON INSERTED THE LENS INTO THE PATIENT'S EYE HE NOTICED THE PRESENCE OF AN ABNORMAL LINE OR MARK ON THE IMPLANT WHEN OBSERVED UNDER MICROSCOPE. SUBSEQUENTLY, IT WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH NEW IOL . ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19050380 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND PROVIDED THE PATIENT HAD VITREOUS INFLAMMATION, CONJUNCTIVAL INFLAMMATION, AQUEOUS CELL WERE SEEN, AQUEOUS FIBRIN PRESENT. VITRECTOMY WAS PERFORMED. IT WAS MENTIONED THAT WHILE INJECTING THE LENS, A SMALL FILMSY MEMBRANE WAS SEEN AT THE EDGE OF THE LENS WHICH WAS REMOVED WITH A GOOD VISCOELASTIC AT THE END. THE PATIENT SYMPTOMS WERE IMPROVING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Conjunctivitis; Endophthalmitis; Fibrosis; Inflammation

  MAUDE report 17333698 ↗
• MalfunctionJun 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A OTHER HEALTHCARE PROFESSIONAL REPORTED THAT LENS TORN OPTIC DURING THE SURGERY. THE LENS WAS EXPLANTED AND IMPLANTED WITH BACKUP LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17071066 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT WAS NOT HAPPY WITH THE OVERALL OUTCOME OF THE SURGERY. IMMEDIATELY POST SURGERY THE PATIENT VISION WAS ALRIGHT. AFTER REACHING TO CANADA THE PATIENT INITIALLY HAD ISSUES OF A LOT OF GLARE. RECENTLY THE VISION FOR FAR AND NEAR WAS NOT SATISFACTORY AND NEEDED GLASSES ALL THE TIME THOUGH THE COMPLAINT ABOUT GLARE HAD REDUCED. ALSO COMPLAINED OF VISUAL DISTURBANCES AND VISION WAS NOT IN THE OPTIMAL RANGE. A YAG WAS PERFORMED. AN LENS EXCHANGE ALSO HAS BEEN ADVISED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT HAD EXPERIENCED HALOS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE RIGHT EYE.

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

  MAUDE report 16863078 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAS NOT SEEN IT PROPERLY SINCE IT WAS PUT ON. THE DOCTOR SAYS THERE WAS NO PROBLEM IN THE SURGERY, BUT PATIENT CANNOT SEE WELL. THERE WAS DOUBLE VISION OR EVEN TRIPLE VISION. THE PATIENT CANNOT SEE THE FACE OF THE PERSON COMING 30 M IN THE SUNLESS CLOUDY WEATHER. THE PATIENT HAS A HARD TIME READING THE TEXTS ON TV FROM 3 METERS (DUE TO THE OVERLAPPING OF THE TEXTS). ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 16784212 ↗
• MalfunctionApr 20, 2023Scratched Material; Scratched Material

  AN OPERATION THEATRE NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FOUND TO BE SCRATCHED. THERE WAS PATIENT CONTACT OBSERVED AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775331 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS POOR VISION AND MECHANICAL FAILURE OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS REPLACED WITH A MONOFOCAL LENS AND THE SYMPTOMS WERE RESOLVED. PHYSICIAN BELIEVE THERE MAY HAVE BEEN A DEFECT WITH THE LENS AS EVERYTHING REGARDING THE HEALTH OF THE EYE AND THE SURGERY OUTCOME WERE NORMAL EXCEPT FOR THE PATIENT'S VISION. NO OTHER EXPLANATION FOR POOR VISION.

  Patient problems: Blurred Vision

  MAUDE report 16460593 ↗
• MalfunctionJan 20, 2023Break; Break

  A PHARMACIST REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS BROKE DURING INJECTION AND THE BACKUP LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16214944 ↗
• MalfunctionDec 1, 2022Difficult to Advance; Scratched Material; Difficult to Advance; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE REPORT OF IMPLANT WAS BLOCKED AT THE ENTRANCE OF THE INJECTOR. DIFFICULTY TO TAKE IT OUT AND TO PUT IT BACK IN WITH AS CONSEQUENCE MARKS ON THE IMPLANT AND DEFECT IN THE CARTRIDGE. THE MARKED IMPLANT WAS IMPLANTED IN THE PATIENT'S EYE, NO CONSEQUENCES FOR THE PATIENT TILL DATE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED LENS SURFACE WAS DAMAGED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT THE MARK ON THE IMPLANT IS MORE LIMITED THAN EXPECTED. WE SHOULD BE ABLE TO AVOID CHANGING THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893542 ↗
• MalfunctionSep 16, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE SAME PATIENT, NOTICED THAT THE POSTERIOR SURFACE OF THE IOL WAS SCRATCHED THROUGH THE CENTER OF THE OPTIC. THE LENS WERE EXPLANTED AND THE PROCEDURE WAS COMPLETED BY IMPLANTING THE ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 15435552 ↗
• MalfunctionSep 15, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE SAME PATIENT, NOTICED THAT THE POSTERIOR SURFACE OF THE IOL WAS SCRATCHED THROUGH THE CENTER OF THE OPTIC. THE LENS WERE EXPLANTED AND THE PROCEDURE WAS COMPLETED BY IMPLANTING THE ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 15424973 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT ABLE TO TOLERATE LENS. HER GLARE WAS WORSE EVEN WITH INSIDE LIGHTING. ALL TESTING AND INTERVENTIONS DONE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR RIGHT EYE. ADDITIONAL INFORMATION RECEIVED THAT, THE PATENT WAS STILL HAVING BLURRY VISION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15359612 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OPTICIAN REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE APPROXIMATELY 5 MONTHS AFTER INITIAL PROCEDURE DUE TO PATIENT SEE VEILS AND HALOS. THE LENS WAS REPLACED WITH MONOFOCAL SINGLE PIECE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 15264061 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIAL MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT STATED HER VISION FEELS OFF, VERY UNHAPPY AND VISION BOTHERS HER. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE WITH A MONOFOCAL LENS IN 2 MONTHS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 15175480 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRY VISION, GLARE AND HALOS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE FIRST EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15131760 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OPHTHALMIC SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD ERROR IN THE REFRACTIVE RESULT DURING THE POSTOPERATIVE CHECK-UP. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 15072553 ↗
• MalfunctionJul 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN OTHER HEALTHCARE PROFESSIONAL REPORTED THAT 3-4 WEEKS AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD BILATERAL MYOPIC OUTCOME. THE SURGEON THOUGHT THAT THE IOL MIGHT BE SITTING MORE ANTERIOR THAN EXPECTED. 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: Visual Disturbances

  MAUDE report 15002897 ↗