AcrySof™ IQ Vivity™ DFT015 (REF DFT015.155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652421140), received between May 25, 2021 and Mar 13, 2025 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE DOCTOR NOTICED A SCRATCH ON THE LENS SURFACE UNDER THE MICROSCOPE BEFORE LOADING IT. THE LENS WAS SET ASIDE, AND NO REPLACEMENT LENS WAS IMPLANTED IN THE PATIENT. THE PATIENT¿S OTHER EYE (LEFT EYE) WAS SUCCESSFULLY OPERATED BUT THE RIGHT EYE PROCEDURE COULD NOT BE FINISHED ON THAT DAY AS THERE WAS NO BACKUP LENS AVAILABLE. TWO DAYS LATER, THE PROCEDURE WAS COMPLETED WHEN THE NEW LENS ARRIVED. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT WAS LEFT APHAKIC ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 21593127 ↗
• MalfunctionJul 20, 2024Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION INTRAOCULAR LENS (IOL) WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19786961 ↗
• InjuryMar 7, 2024Adverse 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, ON THE FIRST FEW WEEKS THE PATIENT HAD SOME ISSUES ABOUT HAVING NO CLEAR INTERMEDIATE VISON AND EVEN NO NEAR VISION. THE RESULT WAS J16 ON THE NEAR. AFTER A MONTH THE PATIENT COMPLAINED THAT THERE WAS NO IMPROVEMENT. SURGEON CHECKED THE PATIENT AND THERE WAS NO UNDERLYING FACTORS. BOTH EYES WERE HEALTHY. AND FOR THE SECOND MONTH SURGEON WANTED TO EXPLANT THE LENS. THE IOL WAS EXCHANGED WITH ANOTHER MODEL OF THE SAME COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 18856766 ↗
• MalfunctionApr 18, 2023Scratched Material; Scratched Material

  A NURSE ADMINISTRATOR REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A LENS MARK WAS NOTICED. THE SURGERY WAS COMPLETED USING BACK-UP LENS. THERE ARE 2 MEDICAL DEVICE REPORTS WITH THIS COMPLAINT. THIS IS 1 OF 2. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16762600 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD VISUAL ACUITY OF 20/50 VISION. ALSO HAD ASTIGMATISM AND DOUBLE-VISION. THE PATIENT COULD SEE CARS IN ORDER TO DRIVE LOCALLY BUT CAN¿T READ MANY OF THE STREET SIGNS. THERE ARE SOME SPOTS IN THE DISTANCE THAT PATIENT CAN SEE WELL BUT WALKING INTO THE GROCERY STORE IS OVERWHELMING AS NOTHING IS CLEAR. DOCTOR ENDED UP DOING A THIRD SURGERY TO REDO THE LEFT EYE. THE THIRD SURGERY WAS ABOUT THREE MONTHS LATER. HAVING THAT MUCH LAPSED TIME CAUSED SURGEON EXTRA CONCERN. THE SURGEON DOESN¿T LIKE THE NEED TO PUT PATIENTS THROUGH EXTRA SURGERIES. HOWEVER THE SURGEON DID IT AND HAD NO PROBLEMS. THE PATIENT IS HAPPY NOW WITH HER FINAL RESULTS. THE PATIENT PROBLEMS NOW ARE AT DUSK/NIGHT, NEEDED TO PUT THE GLASSES BACK ON. THE PATIENT STATED COULD SEE VERY WELL IN THE DAYLIGHT AND LOVE THAT, DON¿T NEED READERS TO DO THE CLOSE-UP PUZZLES. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE SURGERY HAD TO BE REDONE TWICE (TOTAL OF 3 SURGERIES ON OS).

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 13542596 ↗
• InjuryFeb 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD SUBLUXATION OF LENS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480795 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DID NOT ABLE TO SEE VERY WELL AT DISTANCE, AND IN 3 FEET CANNOT SEE THINGS SUCH AS TELEPHONE, THE REMOTE CONTROL FOR THE TV, THE COMPUTER SCREEN, OR ANY PRINT SUCH AS BOOKS OR NEWSPAPER. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT HAD A WRINKLES IN THE EYE AND HAD A YAG (YTTRIUM-ALUMINUM-GARNET) SURGERY AND THERE WAS NO IMPROVEMENT NOTICED IN THE NEAR VISION. NO FURTHER INFORMATION AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

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

  MAUDE report 13168428 ↗
• InjurySep 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  A PHYSICIAN REPORTED THAT APPROXIMATELY 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE, THE IOL WAS EXCHANGED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE PATIENT¿S SYMPTOMS IMPROVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12517989 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED FLICKERING & STROBE LIGHTS WHEN LOOKING DOWN. THE CLINICAL REASON WAS SUBJECTIVE VISUAL, DYSPHOTOPSIA. THE IOL WAS EXPLANTED AND EXCHANGED IN A SECONDARY PROCEDURE FOR A MONOFOCAL IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 12273378 ↗
• InjuryJul 21, 2021Adverse 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 EYE PAIN, INFLAMMATION AND ALSO SAID THAT IT LOOKS LIKE ENDOPHTHALMITIS AT THE HOSPITAL. THE DOCTOR HAD PRESCRIBED THE ANTIBIOTICS AS A TREATMENT AND PATIENT WAS UNDER OBSERVATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Endophthalmitis; Eye Pain; Inflammation

  MAUDE report 12200898 ↗
• MalfunctionJun 1, 2021Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A SCRATCH WAS NOTED ON THE POSTERIOR SURFACE OF THE IOL. THE IOL REMAINS IMPLANTED AND THE SURGEON DOES NOT HAVE CONCERNS ABOUT THE VISUAL ACUITY OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913097 ↗
• InjuryMay 25, 2021Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON THAT THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL WITH THE SAME POWER. THERE WAS NO HARM TO THE PATIENT. THE PATIENT'S ISSUES HAVE RESOLVED AND THE PROGNOSIS IS GOOD.

  Patient problems: Visual Impairment

  MAUDE report 11877946 ↗