AcrySof™ IQ Vivity™ DFT315 (REF DFT315.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652421652), received between Apr 20, 2021 and May 27, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Crack” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT ABLE TO USE THE COMPUTER AND CANNOT READ WITH STANDARD PRINT WITHOUT CORRECTIVE GLASSES. ADDITIONAL TESTS WERE DONE IN ANOTHER CLINIC AFTER THE SURGERY BECAUSE PATIENT THINKS THAT THE LENS WAS NOT FITTED CORRECTLY. THE LEFT EYE WAS BETTER FROM A CLOSER DISTANCE, AND IN THE RIGHT EYE FROM A DISTANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 22086964 ↗
• InjuryMar 25, 2024Adverse 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 GLARE, HALOS AND POOR DEPTH PERCEPTION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 12 MONTHS 19 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18969916 ↗
• InjuryNov 6, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, AS THE LENS CAME OUT OF THE INJECTOR WITHIN THE ANTERIOR CHAMBER, IT WAS NOTICED THAT THE LEADING HAPTIC EDGE HAD BRITTLE WHITE FOREIGN MATTER COATING ALONG IT WHILST FOLDED, WHICH COULD POSSIBLY BE LENS GLIDE MATTER. ADDITIONAL INFORMATION WAS RECEIVED. THE MATERIAL LOOKED LIKE WHITE STICKY PARTICLES LIKE SNOW. THE PHYSICIAN STATED THAT IT MIGHT BE THE LENS GLIDE MATTER THAT IS SOMETIMES ADDED TO THE INSIDE OF THE CARTRIDGES WHICH COULD HAVE CHANGED COLOR FOR SOME REASON. IT LOOKED LIKE IT GOT SCRAPED OUT FROM WITHIN THE CARTRIDGE. IT WAS DEFINITELY FOREIGN MATTER AND NOTHING THAT WAS EVER SEEN BEFORE AND NOTHING FROM THE TRAY. AT THE ONE WEEK VISIT THE PATIENT WAS FINE. NO INFECTION. THE PHYSICIAN TRIED TO RUB IT OFF WITH IRRIGATION/ASPIRATION (I/A) BUT AT LEAST 50% WAS STUCK TOO FIRMLY AND COULDN¿T BE REMOVED. THE LOOSER STUFF WAS ABLE TO BE ASPIRATED.

  Patient problems: Insufficient Information

  MAUDE report 18074603 ↗
• InjuryApr 18, 2023Adverse 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 GREAT RESULT WITH ALMOST 20/20 VISION IN THE DISTANCE AND DECENT FUNCTIONAL VISION AT NEAR. HOWEVER, THE PATIENT NOTICED A CONSTANT OBLIQUE STREAK THROUGH THE CENTER OF VISION MOST VISIBLE AT NIGHT. THE PATIENT FEELS UNCOMFORTABLE DRIVING AT NIGHT BECAUSE OF THIS AND WAS QUIET UPSET. THE PATIENT POSTERIOR CAPSULE SHOWED A FOLD EXACTLY OPPOSITE TO HIS DESCRIPTION, SO SURGEON DID A YAG CAPSULOTOMY HOPING THIS WOULD ALLEVIATE THE ISSUE AND AFTER RETURNING 3 MONTHS, SURPRISINGLY IT DID NOT. THE INTRAOCULAR LENS IS WELL CENTERED AND PATIENTS EYE IS OTHERWISE HEALTHY. THE PATIENT ALSO STATED THE STREAK IS ONLY VISIBLE AT NIGHT WHEN LIGHT IS HITTING PATIENTS EYE. THERE IS POSSIBLY THE FAINTEST GREY LESION NEAR THE CENTRAL OPTIC, BUT NO OBVIOUS DAMAGE FROM THE LENS LOADING OR INSERTION. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, OBLIQUE STREAK IN VISION OF LEFT EYE, MAINLY AT NIGHT DURING DRIVING. THE SYMPTOMS WERE CONTINUING TO THE PATIENT. POSSIBLE LENS EXCHANGE IN FUTURE WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 16761264 ↗
• InjuryMar 7, 2023Malposition of Device; Malposition of Device

  A PHYSICIAN REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE LENS WAS REPOSITIONED FOLLOWING A ROTATION CHECK OF ABOUT 15 DEGREES. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, AFTER THE IOL REPOSITIONING THE PATIENT NOW REACHES 9/10 WITHOUT CORRECTION.

  Patient problems: Visual Impairment

  MAUDE report 16496136 ↗
• MalfunctionJan 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE BROKEN DURING INSERTION. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16173970 ↗
• InjuryNov 4, 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 DECREASED AND BLURRY VISION AND THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MYOPIC SHIFT AND DECREASED VISUAL ACUITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15727950 ↗
• MalfunctionNov 25, 2021Crack; Crack

  A NURSE REPORTED THAT LENS WAS CRACKED AFTER IMPLANTATION. LENS WAS EXPLANTED IMMEDIATELY AND REPLACED WITH ANOTHER IOL IN THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874282 ↗
• MalfunctionNov 25, 2021Crack; Crack

  A NURSE REPORTED THAT LENS WAS CRACKED AFTER IMPLANTATION. LENS WAS EXPLANTED IMMEDIATELY AND REPLACED WITH ANOTHER IOL IN THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874260 ↗
• MalfunctionJun 14, 2021Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED DURING THE INITIAL PROCEDURE DUE TO LACERATION TYPE MARK NOTICED ON THE LENS AFTER INSERTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992821 ↗
• MalfunctionApr 20, 2021Defective Device; Defective Device

  AN OPHTHALMOLOGIST REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE EDGE OF THE LENS WAS NOTED TO HAVE RAGGED EDGES. THE IOL REMAINS IMPLANTED AND THE SURGEON WILL MONITOR THE PATIENT'S OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11693768 ↗