AcrySof™ IQ Vivity™ DFT015 (REF DFT015.240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652421317), received between Apr 7, 2021 and May 22, 2026 — classified as 10 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT VISION WAS VISION A WEEK AFTER THE OPERATION WAS 10/10 WITH SPH -0.75 BUT THE PATIENT MENTIONED THAT SHE HAD FOGGY VISION IN BOTH DISTANCES FAR AND NEAR. THE SURGEON SUGGESTED TO WAIT 2 WEEKS AND CHECK AGAIN THE VISION. POST OPERATIVE 3RD WEEKS THE PATIENT CONTINUED HAD THE SAME REFRACTION BUT SHE WAS STILL NOT HAPPY WITH THE VISION. THE PATIENT WAS MENTIONING A CLOUD FROM THE SIDE, LIKE THE EYE WAS OUT OF FOCUS. THE SURGEON DILATED THE PUPIL AND I FOUND A VERTICAL CRACK EXACTLY ON THE BORDERLINE OF THE ELEVATED PLATEAU OF THE LENS. ON THE (B)(6) 2026 THE SURGEON PERFORMED AN IOL EXCHANGE WITH IMPLANTATION OF A SINGLE PIECE LENS. 10 DAYS POSTOP THE VISION IS 10/10 AND THE PATIENT WAS HAPPY WITH HER VISION. THE SURGEON ASSESSED THAT CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT AS RELATED. THERE WAS NO IMPACT TO THE PATIENT. POST IOL EXCHANGE THE PATIENT HAD COMPLETELY RECOVERED. THERE WAS NO DELAY OCCUR DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT REPORTED DID NOT HAVE A GOOD VISION POST OPERATIVELY, DESCRIBING THE VISION A

  Patient problems: Blurred Vision

  MAUDE report 25255968 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  Additional information was received via the health authority that the patient experienced severe, unresolved visual impairment, including persistent blurred, distorted, and unclear vision at distance, intermediate, and near ranges that was not corrected with spectacles. The patient also experienced photic phenomena, severe glare, starbursts, reflections, chronic ocular dryness, and continuous eye fatigue/strain.

  Patient problems: Dry Eye(s); Eye Irritation; Visual Disturbances; Visual Impairment

  MAUDE report 23976899 ↗
• InjuryNov 11, 2024Scratched Material; Scratched Material

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PHOTOPHOBIA, LIGHT SCATTERING. CLINICAL REASON FOR EXPLANT WAS SCRATCHED IOL. THE IOL WAS EXCHANGED FOR SAME MODEL DIFFERENT DIOPTER ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) COMPANY LENS 4 WEEKS FOLLOWING THE INITIAL IMPLANT PROCEDURE. IN THE SURGEON OPINION IOL AGAINST CARTRIDGE SYSTEM HAD CAUSED OR CONTRIBUTED TO EVENT.

  Patient problems: Insufficient Information; Visual Disturbances

  MAUDE report 20653578 ↗
• MalfunctionDec 6, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED ABOUT A LENS WAS NOT UNFOLDING IN EYE AFTER BEING LOADED IN CARTRIDGE DURING THE PROCEDURE. THE LENS WAS REMOVED. ADDITIONAL INFORMATION WAS RECEIVED FROM INITIAL REPORTER STATING THERE WAS NO PATIENT HARM.

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

  MAUDE report 18278855 ↗
• MalfunctionJun 12, 2023Defective Device; Appropriate Device Problem Term/Code Not Available; Defective Device; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING MICROVACUOLES ARE THE CHANGES IN THE LENS MATERIAL MARKED WITH THE RED ARROWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105485 ↗
• MalfunctionApr 13, 2023Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IOL IMPLANTATION PROCEDURE, DEFECT WAS NOTICED ON THE LENS SURFACE. THE LENS WAS EXPLANTED IN AN INITIAL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 16730891 ↗
• MalfunctionDec 27, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS IMMEDIATE POST IMPLANTATION PARACENTRAL SCRATCHES. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052677 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED BLURRY NEAR AND DISTANCE VISION CAUSING DIZZINESS. HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS INABILITY TO NEURO ADAPT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dizziness; Halo; Headache

  MAUDE report 15995799 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISON AND LENS CANNOT FUNCTION (UNSPECIFIED). THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS ANISOMETROPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15845439 ↗
• MalfunctionNov 7, 2022Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS HAD A DEFECT, IT HAD A SCRATCH IN THE CENTRAL PART OF THE OPTIC. FOR THIS REASON, HE PROCEEDED TO EXTRACT IT, REPORT IT AS A QUALITY COMPLAINT AND IMPLANTED ANOTHER LENS. THERE WAS A 15 MINUTE DELAY BUT THE PROCEDURE WAS COMPLETED, PATIENT IS FINE, ONLY WITH A LITTLE CORNEAL EDEMA AND THE PATIENT WAS RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING PATIENT WAS RECOVERED AND THE CORNEAL EDEMA HAS DISAPPEARED.

  Patient problems: Corneal Edema

  MAUDE report 15750056 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT HAD DETERIORATION OF VISION IN THE RIGHT EYE, THE EYE PRACTICALLY DOES NOT SEE, GLARES AND DISORIENTATION IN SPACE. THE SURGEON PROPOSED TO IMPLANT THE IOL IN THE LEFT EYE, BUT THE CONSUMER IS NOT CONFIDENT ON HAVING AN INSTALLATION IN THE LEFT EYE DUE TO THE NEGATIVE RESULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 15247355 ↗
• MalfunctionJul 15, 2022Scratched Material; Scratched Material

  AN OPHTHALMIC SURGEON REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL) IN THE PATIENT'S EYE NOTED A SCRATCH ON OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT HAS RESIDUAL REFRACTION (MYOPIA). PATIENT HAS GOOD INTERMEDIATE AND NEAR VISUAL ACUITY

  Patient problems: Visual Impairment

  MAUDE report 15025692 ↗
• InjuryMay 26, 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 MYOPIC OUTCOME AND THE PATIENT WAS NOT COMPLETELY SATISFIED WITH THE DISTANCE VISION. TRANSEPITHELIAL PHOTOREFRACTIVE KERATECTOMY (TRANSPRK) WAS PERFORMED WHICH RESOLVED THE PATIENT'S SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 14513912 ↗
• MalfunctionApr 19, 2022Scratched Material; Scratched Material

  A NURSE REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WAS SCRATCHED. THE SURGERY WAS COMPLETED WITH A BACK UP LENS IN THE INITIAL PROCEDURE. PATIENT CONTACT WAS OBSERVED, BUT NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141866 ↗
• MalfunctionMar 10, 2022Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PIECE OF THE LENS WAS BROKEN. THE IOL WAS REMOVED AND REPLACED WITH SAME MODEL LENS DURING THE INITIAL PROCEDURE ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721624 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT CAN'T SEE WELL, HAD MYOPIC OUTCOME. THE IOL EXCHANGED FOR ANOTHER LENS APPROXIMATELY 3 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12591558 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THE FOLLOWING: THE SURGERY WAS PERFORMED, THERE WAS NO ISSUE TO THE PATIENT AFTER THE SURGICAL PROCEDURE, BUT AFTER A WEEK, THE PATIENT'S VISION WAS DECREASED SIGNIFICANTLY, WHICH DID NOT MEET THE STANDARD. THE TARGET WAS ACCURATE, BUT THE LENS WAS EXCHANGED DUE TO THE PATIENT'S COMPLAINT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Blurred Vision

  MAUDE report 12229298 ↗
• MalfunctionMay 24, 2021Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS IMPLANTED THE PHYSICIAN DISCOVERED A NOTICEABLE DEFECT IN THE IOL. IT APPEARS TO BE A BUBBLE IN THE DIMPLE OF THE IOL. THE IOL WAS EXCHANGED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870781 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS IMPLANTATION POST TWO MONTHS LENS WAS EXPLANTED DUE TO UNHAPPY WITH NEAR VISION, BLURRY TO ARM'S LENGTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 11812606 ↗
• MalfunctionApr 7, 2021Material Opacification; Defective Device; Material Opacification; Defective Device

  ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THEY DID NOT USE COMPANY VISCOELASTIC.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626919 ↗