AcrySof™ IQ Vivity™ DFT315 (REF DFT315.225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652421690), received between Aug 18, 2021 and Mar 14, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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.

• MalfunctionMar 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT WHILE INJECTING FOUND A CRACK ON THE LENS. SO, THE LENS WAS NOT USED. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE CRACKED LENS WAS EXPLANTED DURING INITIAL PROCEDURE AND SURGERY COMPLETED ON THE SAME DAY BY IMPLANTING THE SPARE UNSPECIFIED LENS FROM ANOTHER PATIENT WHO HAD A SAME LENS. USED INTRAOCULAR LENS (IOL) CUTER AND ILM FORCEPS TO TAKE OUT LENS FROM EYE. NO IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21603877 ↗
• InjuryJan 10, 2025Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT FOUND THAT THE VISION WAS NOT AS GOOD AS EXPECTED, ONLY POOR NEAR VISION. THE LENS HAD TO BE EXPLANTED AND FOUND A SCRATCH ON THE LENS. THE LENS WAS SCRATCHED WHEN INSERTING INTO THE CARTRIDGE IN INITIAL PROCEDURE. THE LENS WAS EXCHANGED FOR ANOTHER LENS 01 MONTH 18 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, SCRATCH WAS NOTICED DURING THE FOLLOW-UP EXAMINATIONS.

  Patient problems: Blurred Vision

  MAUDE report 21130026 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED LATE ONSET (TOXIC ANTERIOR SEGMENT SYNDROME) TASS, ANTERIOR CHAMBER REACTION WITH FIBRIN, CORNEAL SWELLING, DESCEMET FOLDS AND THE FIBRIN ON THE CAPSULE EDGE. THE PATIENT IS CURRENTLY UNDER TREATMENT AND IMPROVING. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, AS PER THE SURGEON'S OPINION, THE SUSPECTED LATE ONSET OF THE TOXIC ANTERIOR SEGMENT SYNDROME (TASS) COULD BE RELATED TO LENS MATERIAL. THE PATIENT ALSO HAD UNSPECIFIED COMPLAINTS OF THIS EYE IN THE DAYS BEFORE THE EVENT. THE PATIENT HAS BEEN TREATED WITH STEROID OINTMENT AND ANTIBIOTICS. THE PHYSICIAN ALSO STATED THAT, IN THE LEFT EYE THE VISION WENT DOWN FROM 20/25 TO 20/40 AT THE MOMENT AND IS IMPROVING. THE PATIENT ALSO HAD SIGNIFICANT EDEMA VISION WAS DOWN TO 20/200 IN THE LEFT EYE. THE EDEMA DEVELOPED AFTER 2 OR MORE WEEKS, 1 WEEK AFTER SURGERY THERE WAS NO CLINICAL EDEMA PRESENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Conjunctivitis; Corneal Edema; Inflammation; Iritis

  MAUDE report 18308326 ↗
• MalfunctionApr 17, 2023Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DENT OR CRACK WAS FOUND IN THE MIDDLE OF THE LENS WHEN IT WAS INSERTED. THE LENS WAS LOADED AS NORMAL, AND IT PASSED THROUGH THE INSERTER WITH NO NOTED ISSUES. IT WAS EXPLANTED AND REPLACED WITH ANOTHER AT THE TIME OF SURGERY ON THE SAME SESSION. NO ISSUES SINCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752572 ↗
• InjuryNov 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT SOUGHT A SECOND OPINION FROM ANOTHER OPHTHALMOLOGIST. HIS OPINION WAS THAT THE LENSES WERE FINE AND THE SURGEON HAD LEFT SOME WIGGLE ROOM WITH THE LENSES, THAT IS PATIENT WAS WITHIN AN ACCEPTABLE RANGE AND VISION HAS IMPROVED 4 WEEK POST OPERATION. PATIENT WAS STARTED ON ANOTHER STEROID AND WILL BE SEEING ME IN A MONTH. SURGEON STILL SUGGESTED THAT PATIENT MAY NEED A LASIK TREATMENT FOR ONE OF THE EYES TO IMPROVE THE SITUATION.

  Patient problems: Blurred Vision

  MAUDE report 15804356 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT CANNOT SEE DISTANCE OR CLOSE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED PATIENT EXPERIENCING DOUBLE VISION AND CAN FOCUS ABOUT 2 TO 6 FEET. 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 14249596 ↗
• InjuryAug 18, 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, PATIENT EXPERIENCED UNCORRECTED VISUAL ACUITY, DISTANCE VISION AND UNCORRECTED VISUAL ACUITY, NEAR VISION, WHICH DIDN'T GET TARGETS. THERE IS NO OTHER DISEASES. THE LENS WAS REPLACED WITH OTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12338777 ↗