AcrySof™ IQ Vivity™ DFT015 (REF DFT015.235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652421300), received between Mar 5, 2021 and May 16, 2025 — classified as 7 injuries, 11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE WHILE INSERTING THE LENS INTO THE CARTRIDGE, UNUSUAL BEHAVIOR OF THE IOL OCCURRED, THE IOL WAS REMOVED, CHECKED UNDER A MICROSCOPE BY THE SURGEON, AND A LENS CRACK WAS FOUND. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22033953 ↗
• InjuryJun 27, 2024Adverse 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, PATIENT EXPERIENCED IRIS PIGMENTATION MIGRATION. AFTER 6 WEEKS POST-OPERATIVE THE PIGMENTATION/OPACITY IS STILL PRESENT WITH NO IMPROVEMENT IN VISUAL ACUITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Pigment Dispersion Syndrome

  MAUDE report 19622101 ↗
• InjuryApr 22, 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 REASON WAS POOR VISION. CLINICAL REASON BEING RESIDUAL REFRACTIVE ERROR. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 19151459 ↗
• MalfunctionApr 5, 2024Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT LENS FORMED A 1MM LONG GROOVE WHEN APPLIED. THE OPERATION WAS PERFORMED AS STANDARD. WHEN CHECKED BEFORE FOLDING, THE LENS WAS FINE. THE OPERATOR HAS NOTED IN THE PAST MORE DIFFICULT APPLICATION OR GREATER RESISTANCE WHEN APPLYING LENS. THE SCRATCH WAS LOCATED ON THE PERIPHERY OF THE OPTICAL ZONE, THE PATIENT DOES NOT PERCEIVE IT. THERE WAS NO IMPACT ON THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049225 ↗
• MalfunctionMar 20, 2024Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHEN LENS WAS IMPLANTED OBSERVED A VERY CLEAR MARK ON THE OPTIC. THE LENS WAS LEFT IMPLANTED IN PATIENT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18938856 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRA-OCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED OF DISCOMFORT AND UNFAMILIAR SENSATIONS DURING THE ADAPTATION PERIOD OF ABOUT A MONTH . THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 45 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 18181040 ↗
• MalfunctionOct 24, 2023Crack; Crack

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN INJECTING THE LENS INTO THE EYE, IT WAS NOTICED THAT THE LENS HAD A CRACK IN THE MIDDLE OF THE OPTICS. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM AND THE PATIENT IS IN POSTOPERATIVE RECOVERY FROM PHACO SURGERY AND NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996589 ↗
• InjuryJun 5, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS INSERTED SUCCESSFULLY HOWEVER DURING LENS UNFOLDED A CRACK/SCRATCH WAS NOTICED. THE PROCEDURE WAS NOT COMPLETED. THE LENS WAS NOT USED AGAIN. THE PATIENT RETURNED 4 DAYS LATER FOR SECONDARY IMPLANT OF THE SAME TYPE AND STRENGTH LENS. THE PROCEDURE SUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 17057746 ↗
• MalfunctionMar 29, 2023Difficult to Fold, Unfold or Collapse; Defective Component; Difficult to Fold, Unfold or Collapse; Defective Component

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE FAR AND NEAR VISION WAS OF POOR QUALITY AND WAS WORSE THAN BEFORE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE POOR VISION WAS DUE TO DRY EYES AND IS USING LUBRICATING EYE DROPS. IT WAS ADDITIONALLY REPORTED THAT THE EXISTENCE OF VERTICAL BLIND IN THE CORNER OF RIGHT EYE. THIS COULD BE A LENS FOLD. THE REQUESTED TESTS WERE PERFORMED AND THERE IS NOTHING SERIOUS WITH RETINA, JUST NATURAL DEGENERATION DUE TO AGE.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Disturbances

  MAUDE report 16636133 ↗
• MalfunctionSep 27, 2022Scratched Material; Scratched Material

  IT WAS REPORTED BY PHYSICIAN THAT THERE WAS AN ANOMALY AND THE IMPLANT WAS MARKED IN THE MASS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15492990 ↗
• MalfunctionApr 26, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), FOUND THE SCRATCH ON THE LENS. THE PATIENT EXPERIENCED GLARE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT IS UNABLE TO DRIVE IN THE DARK.

  Patient problems: Visual Disturbances

  MAUDE report 14201810 ↗
• InjuryApr 13, 2022Adverse 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 EXPERIENCED POST REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS POST REFRACTIVE SURPRISE AND POST RK (RADIAL KERATOTOMY). ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PATIENT HAD BLURRED VISION. THE CLINICAL REASON FOR EXPLANT MENTIONED AS MYOPIC ASTIGMATISM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 14103167 ↗
• MalfunctionFeb 17, 2022Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THERE WAS A SCRATCH IN THE CENTER OF THE LENS OPTIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13547814 ↗
• MalfunctionSep 1, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED GLISTENING OF IOL OF RIGHT EYE THAT REMAIN ASYMPTOMATIC. NO SERIOUS ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406647 ↗
• InjuryAug 25, 2021Adverse 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 THE VISION PROBLEMS LIKE BLURRY VISION, POOR NEAR AND FAR VISION, MILD REFRACTION BUT INITIATE CHANGES IN OCULAR REFRACTION ONCE TO TWICE A WEEK WITH MULTI-DIPLOPIA ASSOCIATED WITH NAUSEA, ASTIGMATISM. THE PATIENT HAS GOT INTENSIVE OCULAR STEROID (UNKNOWN) TREATMENT. AFTER DISCONTINUATION OF STEROID TREATMENT, PATIENT EXPERIENCED UVEITIS. AGAIN THE PATIENT STARTED THE TREATMENT WITH STEROIDS BUT THERE WAS NO VISUAL IMPROVEMENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS SAID THAT, THE PATIENT HAD CHANGING POSTOPERATIVE VISION, PERMANENT POSTOPERATIVE INFLAMMATION, INFLAMMATORY UVEITIS AND GLAUCOMA WAS RULED OUT AND FINAL DIAGNOSIS MENTIONED AS CYSTOID MACULAR EDEMA. THE PATIENT HAS GOT THE MEDICAL TREATMENT WITH TOPICAL ANTI-INFLAMMATORIES AND ORAL NON STEROIDAL AND TOPICAL STEROID. THE PATIENT WAS RECOVERING FROM THE UVEITIS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Macular Edema; Nausea; Uveitis; Visual Disturbances; Visual Impairment

  MAUDE report 12365468 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS NO PARTICULAR ISSUE WITH THE PATIENT RIGHT AFTER SURGERY, BUT RAPID DETERIORATION OF VISION WAS NOTICED AT THE 2 WEEKS POSTOPERATIVE VISIT. THE LENS EXCHANGE OPERATION WAS PROCEEDED.

  Patient problems: Blurred Vision

  MAUDE report 11915159 ↗
• MalfunctionMay 26, 2021Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED LENS BROKEN NOTICED AFTER INSERTION AND WAS RETRIEVED FROM THE EYE DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. THERE WERE NO CONSEQUENCE TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885956 ↗
• MalfunctionMar 5, 2021Scratched Material; Scratched Material

  A NURSE REPORTED THAT A MARK WAS OBSERVED ON THE SURFACE OF AN INTRAOCULAR LENS (IOL) AROUND MID POINT BETWEEN THE HAPTICS. IT WAS REPORTED BY A COMPANY REP. THAT THERE WAS NO PROBLEMS WITH THE LOADING TECHNIQUE. IT WAS REPORTED THE IOL REMAINS LEFT IMPLANTED AS IT WAS ON THE EDGE AND OUTSIDE OF THE VISUAL AXIS AND CHANCES OF THE PATIENT NOTICING AND HAVING SIDE EFFECTS ARE VERY LOW. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423885 ↗