AcrySof™ IQ Vivity™ DFT015 (REF DFT015.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00380652421294), received between Jul 15, 2021 and Dec 1, 2025 — classified as 10 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (6 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER AROUND TEN MONTHS OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT BEGAN EXPERIENCING PERSISTENT DOUBLE VISION AND GLARE. THESE VISUAL DISTURBANCES SIGNIFICANTLY IMPACTED PATIENT'S ABILITY TO CARRY OUT DAILY TASKS. PATIENT WAS UNABLE TO WORK EFFECTIVELY ON A COMPUTER DUE TO BLURRED VISION, AND DRIVING AT NIGHT BECAME EXTREMELY DIFFICULT BECAUSE OF THE EXTENDED GLARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Disturbances

  MAUDE report 23679554 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER AROUND TEN MONTHS OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT BEGAN EXPERIENCING PERSISTENT DOUBLE VISION AND GLARE. THESE VISUAL DISTURBANCES SIGNIFICANTLY IMPACTED PATIENT'S ABILITY TO CARRY OUT DAILY TASKS. PATIENT WAS UNABLE TO WORK EFFECTIVELY ON A COMPUTER DUE TO BLURRED VISION, AND DRIVING AT NIGHT BECAME EXTREMELY DIFFICULT BECAUSE OF THE EXTENDED GLARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Disturbances

  MAUDE report 23644664 ↗
• MalfunctionMay 9, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED PROBLEMS WITH THE UNFOLDING OF THE TWO HAPTICS OF THE LENS. LENS REMAINED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21994056 ↗
• MalfunctionApr 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION OF COMPANY LENS, A SIGNIFICANT CRACK WAS DETECTED. SUBSEQUENTLY THE LENS WAS EXPLANTED AND OPERATION WAS COMPLETED BUT PATIENT LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21889731 ↗
• MalfunctionMar 25, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANTATION PROCEDURE SURGEON NOTICED A SCRATCH ON THE LENS AFTER IOL INSERTION. THE LENS REMOVED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21687501 ↗
• MalfunctionMar 24, 2025Material Deformation; Material Deformation

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD GLISTENING OF THE IMPLANT. THE LENS REMAINS IMPLANTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT NO SYMPTOMS IN THE DAYS FOLLOWING SURGERY. THE GLISTENING'S APPEARED 3 YEARS AFTER IMPLANTATION. NO ACTION HAS BEEN TAKEN, THE SURGEON WILL SEE OVER TIME WHETHER OR NOT THE GLISTENING'S STABILIZE.

  Patient problems: Insufficient Information

  MAUDE report 21677760 ↗
• MalfunctionMar 24, 2025Material Deformation; Material Deformation

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD GLISTENING OF THE IMPLANT. THE LENS REMAINS IMPLANTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT NO SYMPTOMS IN THE DAYS FOLLOWING SURGERY. THE GLISTENING'S APPEARED 3 YEARS AFTER IMPLANTATION. NO ACTION HAS BEEN TAKEN, THE SURGEON WILL SEE OVER TIME WHETHER OR NOT THE GLISTENING'S STABILIZE.

  Patient problems: Insufficient Information

  MAUDE report 21676631 ↗
• MalfunctionJan 2, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING LOADED THE HAPTIC WAS BROKEN NO PATIENT CONTACT. THE PROCEDURE WAS NOT COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE IOL TRAILING HAPTIC BROKE DURING LOADING AND WAS NEVER USED WITH NO PATIENT CONTACT AND NO PATIENT HARM. IOL WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053569 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED ABOUT VISION BECAME BLURRY AFTER GOOD INITIAL POST-OP RECOVERY. THE SYMPTOM IS STILL ONGOING. ADDITIONAL INFORMATION WAS RECEIVED FROM PHYSICIAN STATING THE PATIENT'S RIGHT EYE VISUAL ACUITY WAS ALWAYS BETWEEN 9 AND 10/10. THERE IS NO ISSUE WITH RIGHT EYE. ADDITIONAL INFORMATION WAS RECEIVED FROM CONSUME STATING SHE WAS STILL CONSIDERING HAVING THE IMPLANTS REMOVED AS IT HAS HUGE IMPACT ON LIFE AND MORALE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20914141 ↗
• InjuryNov 18, 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, SPICULAR 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. SYMPTOMS ARE CONTINUING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. LE VA WITH IOL. 0.9 OU VA AT NEAR 0.9DIF ¿ FLUCTUATES ARX MEASUREMENT. - LE -0.50 TO 113º SUBJECTIVE RX: LE -0.50 115º AVCC 0.9 NORMAL CONTRAST SENSITIVITY AND THE SAME IN OU.

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

  MAUDE report 20707633 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM CONSUMER STATING THE SYMPTOMS WERE ONGOING AND STILL CONSIDERING HAVING THE IMPLANTS REMOVED, AS THE TWO "VEILS" WERE HAVING A HUGE IMPACT ON LIFE AND MORALE. BEST CORRECTED PREOPERATIVE VISUAL ACUITY: OS 8/10 P2. BEST CORRECTED POST-OPERATIVE VISUAL ACUITY (ON 18-DEC-2023): OS 9/10. UNCORRECTED PRE-OPERATIVE VISUAL ACUITY: OS 4/10. UNCORRECTED POST-OPERATIVE VISUAL ACUITY: OS 8/10.

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 20011509 ↗
• MalfunctionMay 6, 2024Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANTATION (IOL) PROCEDURE, THEY NOTICED A FOLD MARK ON THE OPTIC OF AN IMPLANT, WHICH PERSISTED AFTER THE IMPLANT HAD BEEN DEPLOYED IN THE PATIENT'S EYE. THE LENS WAS RETAINED IN PATIENT'S EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19247504 ↗
• MalfunctionMar 15, 2024Material Deformation; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED IOL WAS DAMAGED DURING THE INJECTION PROCESS, AND THE LENS HAD TO BE FOLDED OVER AND TAKEN OUT OF THE EYE. THE BACK UP WAS USED AND PATIENT UNHARMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE DAMAGE WAS DUE TO THE ARCHAIC METAL - IOL MECHANISM THAT COMPANY NEED IMPROVING WITH PRE LOADED IOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18911273 ↗
• MalfunctionFeb 2, 2024Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, A MARK WAS NOTICED ON THE OPTIC OF THE LENS WHICH WAS VISIBLE UNDER THE MICROSCOPE AFTER IMPLANTATION. AS PER THE SURGEON, THE MARK WOULD NOT BE VISIBLE OR UNCOMFORTABLE FOR THE PATIENT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629229 ↗
• InjuryJan 1, 2024Break; Optical Decentration; Material Twisted/Bent; Break; Optical Decentration; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. WHEN SURGEON IMPLANTED THE LENS THE IOL WAS NOT CENTERED DUE TO HAPTIC BENT. THE HAPTIC WAS BROKEN WHEN TRIED TO ADJUST THE LENS. WHEN THE LENS WAS ROTATED, IT FAILED TO FIXATE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT DURING THE ORIGINAL PROCEDURE, THERE WERE DIFFICULTIES IN CENTRATION, THE PUPIL WAS CONSTRICTED. THE LENS WAS NOT EXPLANTED, WHEN AN ATTEMPT WAS MADE TO REPOSITION IOL THE LOWER HAPTIC WAS BENT AND STUCK TO THE OPTICAL PART. THE HAPTIC WAS PUSHED WITH A MANIPULATOR AND IT FELL OFF. THE IOL WAS POSITIONED BY HOOKING THE HAPTIC STUMP TO THE EDGE. IF THE LENS DOES NOT CHANGE ITS POSITION WITHIN 14 DAYS THEN THE IOL SHOULD NOT BE REPLACED. IF IT CHANCES THE POSITION, IOL SHOULD BE REPLACED. THE PATIENT WAS HOSPITALIZED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18423133 ↗
• 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 LOW ANTERIOR CHAMBER REACTION, CORNEAL SWELLING, DESCEMET FOLDS. 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 HAS BEEN TREATED WITH STEROID OINTMENT AND ANTIBIOTICS. THE PHYSICIAN ALSO STATED THAT, AT THE MOMENT THE RIGHT EYE STILL HAS SOME EDEMA BUT THE VISION IS BACK TO 20/20. 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 RIGHT EYE.

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

  MAUDE report 18308720 ↗
• InjuryNov 20, 2023Break; Optical Decentration; Break; Optical Decentration

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT CAME BACK TO HOSPITAL 2 TIMES AND GOT THE LENS ROTATED BECAUSE OF DISLOCATION. THE THIRD TIME THE PATIENT WAS SEND TO ANOTHER CLINIC TO REMOVE THE LENS, AND IT WAS AT THAT POINT IT WAS OBSERVED THAT ONE HAPTIC WAS BROKEN. THE IOL WAS EXCHANGED FOR COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED DURING INITIAL IMPLANTATION, THE SURGERY WENT ACCORDING TO PLAN. HOWEVER, THE IOL HAD DIFFICULTY CENTERING PROPERLY AND TEND TO SHIFT TEMPORALLY. NEXT MONTH, THE IOL WAS NOT CENTERED TWICE AND WAS REPLACED TWICE WITHOUT COMPLICATIONS. LATER MONTH, IOL WAS AGAIN FOUND TO BE DECENTERED. THE IOL WAS REMOVED FROM THE LENS BAG AND IT WAS DISCOVERED THAT THE LENS BONE HAS BROKEN OFF THE LENS. THERE WAS NO PATIENT HARM AND THE TREATMENT WAS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18168690 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED EXTREMELY BLURRED VISION AND NOTICED ONLY SUBTLE IMPROVEMENTS. THE PATIENT CONSULTED THE DOCTOR AND THE DOCTOR RECOMMENDED A DEGREE OF NEAR, FAR AND AXIS. THE PATIENT CAN SEE AT A DISTANCE OF 1.5M AND FROM THERE THE VISION GETS SHADED. THE PATIENT DOES NOT HAVE CLEAR NEAR VISION AND HE COULD NOT READ SHAMPOO LABEL OR CELL PHONE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 17582776 ↗
• MalfunctionJan 4, 2023Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE LENS ITSELF DID NOT CONTRIBUTE TO THE DAMAGE, IT WAS THE LOW TEMPERATURE OF THE OPERATING ROOM (OR) THAT CAUSED THE LENS TO BE RIGID AND BECOME DAMAGED WHEN BEING MANIPULATED INSIDE OF THE CARTRIDGE". THE ISSUE WAS OBSERVED DURING LOADING. AS IT WAS THE FIRST CASE OF THE DAY IT WAS LIKELY MUCH BELOW ROOM TEMPERATURE AS IT WAS TAKEN OUT OF THE FRIDGE NOT LONG BEFORE. IN ADDITION THE OPERATING ROOM (OR) TEMPERATURE WAS AT 12 DEGREES CELCIUS, LIKELY KEEPING THE VISCOELASTIC COOL.

  Patient problems: Insufficient Information

  MAUDE report 16094644 ↗
• MalfunctionDec 16, 2022Crack; Crack

  A PHYSICIAN REPORTED AFTER THE INTRAOCULAR LENS IMPLANTATION INTO THE PATIENT'S EYE, THE SURGEON NOTICED A CRACK IN THE IMPLANTED LENS. ADDITIONAL INFORMATION WAS RECEIVED AND PATIENT DETAILS UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 15995245 ↗
• MalfunctionJul 13, 2022Defective Device; Defective Device

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION, IOL FOUND TO BE DAMAGED AFTER PHACOEMULSIFICATION. THE PHYSICIAN REMOVED THE LENS. THERE WAS NO PATIENT HARM. THE PATIENT HAS BEEN RECOVERED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15002266 ↗
• InjuryFeb 12, 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 BLURRY AND CLOUDY VISION, MECHANICAL FAILURE. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND WAS REPLACED WITH A BACK UP LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13519089 ↗
• MalfunctionDec 22, 2021Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT, DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A MARK ON THE PERIPHERY OF THE LENS POST INJECTING LENS INTO THE EYE. THE SURGEON DECIDED NOT TO EXPLANT THE IOL AS THE SCRATCH WAS NOT ON THE VISUAL AXIS OR LENS TRANSITION ELEMENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13058146 ↗
• MalfunctionSep 30, 2021Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THERE WAS A SCRATCH ON THE LENS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SCRATCH WAS NOTICED AFTER THE LENS WAS INJECTED INTO THE EYE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554678 ↗
• MalfunctionJul 15, 2021Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE SURGEON REALIZED THAT THE LENS IMPLANTED IN SAC WAS SCRATCHED. THE PROCEDURE WAS COMPLETED USING BACK UP LENS ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12175685 ↗