AcrySof™ IQ Vivity™ DFT015 (REF DFT015.225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00380652421287), received between Mar 24, 2021 and Dec 22, 2025 — classified as 21 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (15 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO HAVE MARK ON IT. THE COMPANY DELIVERY SYSTEM WAS USED ALONG WITH COMPANY OPHTHALMIC VISCOSURGICAL DEVICES (OVD). NO ISSUES OCCURRED DURING THE FOLDING OF THE IMPLANT. THE PATIENT HAD NOT YET ATTENDED THE POST-OPERATIVE CONSULTATION TO DETERMINE WHETHER THE MARK IS CAUSING ANY DISCOMFORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND STATED THAT THE IMPLANT INSPECTED BEFORE THE FOLDING HOWEVER NOT UNDER A MICROSCOPE. AS PER THE REPORTER INJECTOR NOZZLE TOUCHED THE OPTICS DURING IMPLANT INJECTION AND WOULD HAVE CAUSED THE SCRATCH/MARK. IT WAS ALSO STATED A SUDDEN JERK WAS FELT MIDWAY THROUGH THE INJECTION. THE PHYSICIAN SAW THE PATIENT AGAIN. THE MARK WAS LOCATED AT THE PUPILLARY MARGIN. THE PATIENT DID NOT EXPERIENCE ANY DISCOMFORT, AND EXPLANATION WAS NOT PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864655 ↗
• InjuryJul 21, 2025Adverse 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 POOR QUALITY VISION AND DOUBLE VISION AT DISTANCE. PATIENT WAS WEARING SPECTACLES ALL THE TIME AND NEEDS TO REMOVE THEM IN CASE OF CLOSER VISION ACTIVITIES WHILE USING MONITOR, WHILE READING AND USING PHONE. THE LENS REMAINS IMPLANTED IN THE EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 22554252 ↗
• InjuryJul 18, 2025Adverse 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 POOR QUALITY VISION AND DOUBLE VISION AT DISTANCE. PATIENT WAS WEARING SPECTACLES ALL THE TIME AND NEEDS TO REMOVE THEM IN CASE OF CLOSER VISION ACTIVITIES WHILE USING MONITOR, WHILE READING AND USING PHONE. THE LENS REMAINS IMPLANTED IN THE EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 22546417 ↗
• MalfunctionJun 27, 2025Break; Break

  A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF NO HAPTIC OF INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22345574 ↗
• MalfunctionMay 27, 2025Failure to Deliver; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE THE LENS GOT STUCK IN THE SHOOTER. THE PROCEDURE WAS COMPLETED WITH THE BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087587 ↗
• InjuryApr 30, 2025Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT LENS OPTIC SCRATCHED AND IT WAS OBSERVED THE DEFECT DURING THE IMPLANTATION. UNFORTUNATELY, NO OTHER IOL (INTRAOCULAR LENS) OF THE SAME DIOPTER WAS AVAILABLE IN THE CLINIC SO THEY HAVE IMPLANTED THE DEFECTIVE LENS AND COMPLETED THE SURGERY. ON 1ST POST OPERATION DAY PATIENT REPORTED VISUAL DISTURBANCE CORELATED TO THE DEFECT OF THE OPTIC. ON 5TH POST OPERATION DAY DOCTOR RECEIVED THE SAME COMPLAINT FROM THE PATIENT. SO, THEY HAVE EXPLANTED THE DEFECTIVE IOL AND NEW UNSPECIFIED VIVITY LENS HAS BEEN IMPLANTED. SURGERY HAS FINISHED SUCCESSFULLY AND THE PATIENT DOES NOT HAVE ANY COMPLAINTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 21933372 ↗
• InjuryFeb 11, 2025Optical Decentration; Optical Decentration

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, PATIENT WAS UNABLE TO SEE THE OBJECTS CLEARLY AND EVERYTHING WAS APPEARING CLOUDY. DOCTOR HAS EXAMINED THE EYE AND INFORMED THAT THE EYE WAS PERFECT. THE ISSUE MAY BE WITH THE LENS, BECAUSE OF WHICH THE PATIENT WAS UNABLE TO GET THE VISION. ADDITIONAL INFORMATION RECEIVED AND IT STATES THAT THE PATIENT CONDITION ON DISCHARGE WAS STABLE. NO EYE PAIN AND FIT FOR DISCHARGE, THE COURSE IN HOSPITAL WAS UNEVENTFUL. PATIENT ADMITTED, OPERATED, DISCHARGED IN SAME DAY WITHOUT ANY COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED AND IT STATES THAT THE PATIENT WHILE PERFORMING SURGERY, SAME LENS IMPLANTED IN THE SULCUS. ON THE NEXT DAY PATIENT CAME FOR A POST-OPERATIVE FOLLOW-UP WITH A CLEAR CORNEA BUT A DECENTERED INTRAOCULAR LENS (IOL) NOTED. REPOSITIONING OF IOL WAS PERFORMED ON THE SAME DAY. ALSO, ON THE OTHER DAY PATIENT PRESENTED WITH HIGH INTRAOCULAR PRESSURE (IOP) BUT WAS COMFORTABLE AFTER RECEIVING MEDICATIONS. DURING THE FOLLOW-UP, THE PATIENT'S UNAIDED VISION WAS RECORDED AS 6/6 P, AND THE BEST CORRECTED VISION WAS ALSO 6/6 P. DOCTOR HAS ADVISED THE PATIENT TO PROCEED WITH SECOND EYE IMPLANT. HOWEVER, THE PATIENT HAS NOT RET

  Patient problems: Blurred Vision; Intraocular Pressure Increased

  MAUDE report 21354293 ↗
• InjuryFeb 10, 2025Adverse 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 VISION BLURRY AND EXTREME LIGHT SENSITIVITY. THE LENS WAS EXCHANGED FOR ANOTHER LENS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATIONS.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21342663 ↗
• MalfunctionJan 7, 2025Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE PRIMING THERE WAS RESISTANCE IN DELIVERY SYSTEM, HARD TO PUSH AND PLUNGER WAS STIFF. WHEN LENS WAS BEING INJECTED, IT WAS NOTED THAT THE EMBOLUS ENTERED A PART INSIDE THE LENS HAPTIC. THE LENS WAS REMOVED FROM THE CARTRIDGE AND THE LENS WAS DETERIORATED AT THE EDGE, ALSO ONE OF THE HAPTICS DESPITE BEING OUTSIDE THE CARTRIDGE DID NOT RECOVER ITS SHAPE. SO, IT WAS DECIDED NOT TO IMPLANT THE LENS. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21090730 ↗
• MalfunctionDec 27, 2024Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A PHYSICIAN REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON LOADED THE LENS INTO THE CARTRIDGE, WHEN THE PISTON ADVANCED HE FELT AN ABNORMAL RESISTANCE TO SLIDING, SUSPICIOUSLY HE PUSHED THE LENS OUT ONTO THE OPERATING TABLE, WASHED IT AND NOTICED SCRATCHES ON THE LENS, PROBABLY CAUSED BY THE PISTON DURING SLIDING. THERE WAS NO PATIENT HARM . ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025216 ↗
• InjuryNov 15, 2024Material Opacification; Adverse Event Without Identified Device or Use Problem; Material Opacification; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY HAVE BEEN INFORMED OF ADAPTATION PROBLEMS IN A PATIENT EXPERIENCED PHOTOPSIA, ROUND HALOS, IT HAPPENS IN MESOPIC CONDITIONS (AT DUSK OR EARLY IN THE MORNING, MORE IN THE AFTERNOON), DOES NOT CALCULATE DISTANCES WELL AND HAS ALSO LOST SENSITIVITY TO CONTRAST, THERE WAS A SLIGHT OPACITY.(YTTRIUM ALUMINUM GARNET) YAG CAPSULOTOMY WAS PERFORMED. DYSPHOTOPSIA WAS DUE TO THE EFFECT OF A POORLY REACTIVE MIOTIC PUPIL.SYMPTOMS ARE CONTINUING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. AR. NEUTRAL OD OU VA AT NEAR 0.9DIF ¿ FLUCTUATES ARX MEASUREMENT.- OD -0.25 TO 111º SUBJECTIVE RX: OD -0.25 , VACC 1 NORMAL CONTRAST SENSITIVITY AND THE SAME IN OU.

  Patient problems: Blurred Vision; Halo; Posterior Capsule Opacification; Visual Disturbances; Visual Impairment

  MAUDE report 20696500 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Scratched Material; Adverse Event Without Identified Device or Use Problem; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER 4 MONTHS OF SURGERY, THEY HAVE NOTICED WHITE DUSTS OR SPOTS ON THE OPTIC SURFACE. PATIENT ALSO HAD VA (VISUAL ACUITY) DROPS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATES THAT PATIENT NOT HAD PCO (POSTERIOR CAPSULE OPACIFICATION) ACCORDING TO THE SURGEON¿S FEEDBACK AND IT¿S LIKE UVEITIS SYMPTOMS BUT PATIENT CLAIMED THAT SHE DIDN¿T HAVE ANY INFECTION AFTER SURGERY AND SURGEON PRESCRIBED EYE DROPS.

  Patient problems: Uveitis; Visual Impairment

  MAUDE report 20641855 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING VISION DETERIORATES FROM PRE TO POST OPERATION AND PATIENT ISSUE WAS RESOLVED.

  Patient problems: Endophthalmitis

  MAUDE report 19124451 ↗
• MalfunctionMar 5, 2024Scratched Material; Scratched Material

  A PHARMACIST REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A MARKING IN THE CENTER, TWO MARKINGS IN THE OPTICAL ZONE. THE LENS WAS IMPLANTED AND EXPLANTED DURING INITIAL PROCEDURE BY CUTTING HALF. THERE WAS NO PATIENT HARM REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18834965 ↗
• MalfunctionMar 4, 2024Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT, THE INTRAOCULAR LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18826452 ↗
• MalfunctionFeb 16, 2024Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18720501 ↗
• MalfunctionJan 8, 2024Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, STRAIGHT SCRATCH ON IOL OPTIC NOTICED. THIS HAS OCCURRED IN THE PAST AT THIS SITE AND THE FACILITY FEELS IT MAY RELATE TO THE MONARCH INJECTOR. IOL WAS STILL INSIDE THE PATIENT EYE, SCRATCH WAS IN PERIPHERY OF IOL SO WILL NOT AFFECT THE VISION.

  Patient problems: Insufficient Information

  MAUDE report 18463659 ↗
• InjuryOct 5, 2023Adverse 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 LENS DID NOT CORRECT VISION OF PATIENT. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 17874830 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THERE WAS DIFFICULTY WITH LIGHTS, SUN. THE VISION WAS VERY BLURRY, THERE WERE LOTS OF HALOS AND CONSUMER ALSO EXPERIENCED ASTIGMATISM. DIFFERENT EYE DROPS WERE PRESCRIBED. CONSUMER HAD GLASSES WITH PROGRESSIVE FOCUS, ADDITION OF EXTRACTIVE TRANSITION, WHICH HELPED IN VERY LIT PLACES. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 17641509 ↗
• MalfunctionAug 24, 2023Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED THAT THE LENS WAS SCRATCHED IN THE CORNER WHICH WAS WEIRD BECAUSE OF THE LOCATION OF THE SCRATCH. THE SCRATCH WAS NOT IN THE LOCATION WHERE THE FORCEPS NORMALLY TOUCHES. THE LENS WAS LOADED NORMALLY. THE LENS WAS LEFT IN THE PATIENT'S EYE AND WAS NOT EXPLANTED. THE LENS WAS ALWAYS LOADED CORRECTLY IN THE LENS.

  Patient problems: Insufficient Information

  MAUDE report 17611066 ↗
• MalfunctionJun 26, 2023Scratched Material; Scratched Material

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, WHEN THE LENS WAS IMPLANTED NOTICED A SCRATCH IN THE PERIPHERAL PART OF THE OPTIC. THE LENS WAS RETAINED IN THE EYE AS THE SCRATCH WILL BE UNDER THE PUPIL, NO VISUAL DISTURBANCES ARE EXPECTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 1 OF 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199807 ↗
• MalfunctionJun 26, 2023Scratched Material; Scratched Material

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE REASON FOR THE 3 SUPERFICIAL "SCRATCHES" ON THE SURFACE IS ASSUMED TO BE SCRATCHING OF THE CARTRIDGE OR A CHANGE OF THE SURFACE OF THE IOL UNDER THE COMPRESSION DURING THE COMPRESSION IN THE CARTRIDGE. THE PATIENT COMPLAINS ABOUT OCCASIONAL OPTICAL SCATTERING PHENOMENA AT DUSK, NOT DURING THE DAY. HOWEVER, SHE DOES NOT WANT TO HAVE AN EXPLANTATION PERFORMED. THE SCRATCHES WERE DOCUMENTED POSTOPERATIVELY AND ALSO COMMUNICATED TO THE PATIENT.

  Patient problems: Visual Impairment

  MAUDE report 17197940 ↗
• MalfunctionFeb 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE MATERIAL WAS NOTED ADHERED TO THE BACK OF THE LENS WAS TRANSPARENT AS IF IT WAS A MEMBRANE OUTLINING THE SWIPE. THE SURGEON REMOVED THE MATERIAL USING IRRIGATION AND ASPIRATION CLEANING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16361715 ↗
• MalfunctionJan 4, 2023Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SCRATCHES AT THE PERIPHERY OF THE OPTIC OF IOL. THE PHYSICIAN LEFT THE IOL IN AS DOESN¿T THINK IT WOULD AFFECT THE PATIENTS VISUAL ACUITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16093110 ↗
• InjuryDec 30, 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 VISION WAS AT ADDITION +2 AND .50 CYL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT IS NOT SATISFIED NEAR VISION.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16076676 ↗