AcrySof™ IQ Vivity™ DFT015 (REF DFT015.150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652421133), received between Oct 25, 2021 and Apr 22, 2025 — classified as 4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAD SMALL SCRATCH PERIPHERALLY ON THE OPTIC NOTICED ON IOL AFTER IMPLANTATION. IOL WAS LEFT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21880921 ↗
• MalfunctionMar 26, 2025Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED DURING SURGERY SURGEON NOTICED A CRACK AND SCRATCH ON THE LENS AFTER INSERTION. SO, THE LENS WAS TAKEN OUT FROM EYE IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE LENS WAS REMOVED ON THE SAME DAY DURING INITIAL PROCEDURE AND NEW UNSPECIFIED BACKUP LENS WAS IMPLANTED. NO PATIENT IMPACT WAS REPORTED. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694813 ↗
• InjuryJul 15, 2024Adverse 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. LENS APPEARED TO HAVE SETTLED DOWN, BUT HE DID NOT HAVE ANY FUNCTIONAL NEAR OR INTERMEDIATE VISION. ALTHOUGH, DISTANCE APPEARED FINE. HE HAD NO OTHER EYE PROBLEMS. HE STATED, HIS APPOINTMENT WITH HIS SURGEON HAS BEEN SCHEDULED, WHERE SURGEON WOULD SUGGEST SOME ADJUSTMENTS FOR THE SECOND EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. RECEIVED AND STATED, THE PATIENT OCCASIONALLY WEARS SOFT CONTACT LENSES, BUT NOT WITHIN A WEEK OF MEASUREMENT. HE WAS RELUCTANT TO HAVE THE IOL IMPLANTED IN OTHER EYE, UNTIL THERE IS NO ESTABLISHMENT WHY THE FIRST HAS NO FUNCTIONAL READING OR INTERMEDIATE VISION. THE CONSUMER MET WITH HIS EYE SURGEON FOR AN UPDATE, CONCERNING LACK OF FUNCTIONAL READING AND INTERMEDIATE VISION. THE CONSUMER WAS UNWILLING TO GO AHEAD WITH SURGERY ON HIS OTHER EYE, BEFORE IT IS ESTABLISHED, WHY THE FIRST SURGERY DID NOT RESULT IN THE ANTICIPATED BENEFITS. HE HAS BEEN EXPERIENCING CONSIDERABLE DIFFICULTY WITH ONE FUNCTIONAL EYE.

  Patient problems: Blurred Vision

  MAUDE report 19739951 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AT ALL DISTANCES. THE NEAR RANGE WAS PARTICULARLY BAD. A POST-CATARACT WAS TREATED WITH A LASER. SINCE THEN, PATIENT HAVE SUFFERED FROM UNBEARABLE STARBURSTS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, STATING THE PATIENT WORE CONTACT LENSES ANYWAY, ONLY QUITE SPORADICALLY DURING VARIOUS LEISURE ACTIVITIES. THE STARBURSTS ARE UNBEARABLE, AND THESE OCCURRED AFTER YAG (YTTRIUM ALUMINUM GARNET) AND WERE NOT PRESENT BEFORE. NO CONTACT GLASS WAS USED DURING THE LASER TREATMENT. THE PATIENT WAS SUFFERING FROM THE VISION RESTRICTIONS AND STARBURSTS THAT SHE HAS ALREADY BEEN ON SICK LEAVE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16394420 ↗
• InjuryMar 23, 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 HAD MISREFRACTION (MYOP). LASER TOUCH-UP WAS PERFORMED (BECAUSE DOMINANT EYE). IT WAS REPORTED THAT PATIENT IS VERY SATISFIED AND NO LONGER NEEDS GLASSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 13862627 ↗
• InjuryFeb 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION, DOUBLE VISION AND SUBLUXATION. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL APPROXIMATELY 7 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13548528 ↗
• MalfunctionOct 25, 2021Defective Component; Defective Component

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689552 ↗