AcrySof™ IQ Vivity™ DFT015 (REF DFT015.180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652421195), received between Jun 1, 2021 and Jul 29, 2025 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A SCRATCH WAS OBSERVED ON THE LENS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER ONE. AS THE LENS WAS DAMAGED AND POSED A POTENTIAL RISK OF CONTAMINATION DURING TRANSPORT, IT WAS NOT RETAINED. ADDITIONAL INFORMATION WAS RECEIVED AS AFTER LENS INJECTION AND ITS UNFOLDING INSIDE THE EYE.

  Patient problems: Insufficient Information

  MAUDE report 22645843 ↗
• MalfunctionJul 24, 2025Break; Break

  A PHARMACIST REPORTED WITH A DESCRIPTION OF IMPLANT NOT PLACED DUE TO INTRAOCULAR LENS (IOL) BROKEN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22585683 ↗
• MalfunctionOct 25, 2024Material Opacification; Material Opacification

  A HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DEVELOPED INTRA-LENTICULAR OPACIFICATION TWO YEARS LATER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20531538 ↗
• MalfunctionFeb 9, 2023Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS DISCOVERED ON THE IOL IMMEDIATELY AFTER IMPLANTATION. THE IOL WAS POLISHED WITH THE IRRIGATION AND ASPIRATION HANDPIECE AND SO THE SCRATCH WAS MITIGATED. IOL REMAINS IN THE EYE. THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335422 ↗
• InjuryDec 28, 2022Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER LENS WAS INTRODUCED, IT CAME WITH DEFECTIVE/BROKEN HAPTICS. THE PATIENT ALSO HAD RUPTURE OF THE POSTERIOR CAPSULE WITH VITREOUS LOSS.

  Patient problems: Capsular Bag Tear; Vitreous Loss

  MAUDE report 16059611 ↗
• InjuryMay 9, 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 COULD NOT SEE WELL AND THE OBJECTS LOOKED CURVED WHEN LOOKING FROM LONG DISTANCE, THE OBJECTS LOOKED CURVED WHEN LOOKING FROM LONG DISTANCE. RE-EXAMINATION RESULTS THAT HYPEROPIC REFRACTIVE ERRORS WAS CONFIRMED. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 14340758 ↗
• InjuryJan 27, 2022Adverse 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 HAD HORRIBLE VISION AND WORSE THAN BEFORE SURGERY WITHOUT GLASSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT THE PATIENT IS COMPLETELY DEPENDING ON READING GLASSES TO SEE ANYTHING AT NEAR. HER DISTANCE VISUAL ACUITY IS OK, BUT NOT GREAT, RESIDUAL ASTIGMATISM AND HISTORY OF RETINA ISSUES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13367365 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT WAS VERY UNHAPPY AND FELT THE LENS DID NOT WORK FOR THE NEAR VISION. ADDITIONAL INFORMATION WAS RECEIVED STATING ONE TO FOUR WEEKS POST OPERATIVELY THE NEAR VISION HAD DECREASED TO 20/100.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13266201 ↗
• InjuryNov 25, 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, THE PATIENT WAS UNABLE TO FOCUS. THE IOL EXCHANGED FOR ANOTHER LENS 7 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 12874465 ↗
• InjuryNov 13, 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, THE PATIENT'S VISION DID NOT IMPROVE AND EXPERIENCED GLARE. THE IOL WAS EXCHANGED FOR ANOTHER LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 12808113 ↗
• InjurySep 28, 2021Adverse 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¿S VISION WAS BAD, HAD TROUBLE WITH GLARE, AND DINT FEEL SAFE DRIVING THE MOTORCYCLE. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL, IN A SECONDARY PROCEDURE 105 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12538884 ↗
• MalfunctionJun 1, 2021Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAD A FUNNY MARK NEXT TO THE VISUAL AXIS IN THE IOL. A SECOND IOL WAS INSERTED AND IT HAD A SIMILAR MARK BUT THE MARK WAS SMALL ENOUGH THAT THE IOL WAS LEFT IMPLANTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE TWO MARKED LENSES. THIS REPORT IS FOR THE SECOND IOL WITH A MARK THAT REMAINED IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913190 ↗
• MalfunctionJun 1, 2021Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAD A FUNNY MARK NEXT TO THE VISUAL AXIS IN THE IOL. A SECOND IOL WAS INSERTED AND IT HAD A SIMILAR MARK BUT THE MARK WAS SMALL ENOUGH THAT THE IOL WAS LEFT IMPLANTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE TWO MARKED LENSES. THIS REPORT IS FOR THE FIRST IOL WITH A MARK THAT WAS INSERTED AND REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11913183 ↗