AcrySof™ IQ Vivity™ DFT415 (REF DFT415.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652422116), received between Mar 5, 2021 and Sep 27, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE LENS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 4.

  Patient problems: Insufficient Information

  MAUDE report 20323109 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THEY HAVE 3 OR 4 CASES OF IRVINE GASS MACULAR EDEMA IN PATIENTS IMPLANTED WITH LENSES. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED ,PATIENT DETAILS WERE PROVIDED AND THIS REPORT IS FOR 68 YEAR OLD PATIENT. AFTER SURGERY ACUITY 1 WAS PERFECT FOR HER, BUT 2 WEEKS LATER SHE CAME IN DUE TO SUDDEN LOSS OF VISION IN THE OPERATED EYE LE.

  Patient problems: Macular Edema

  MAUDE report 19726448 ↗
• InjuryMar 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CLINICAL ASSOCIATE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS MISALIGNED NEEDING AN INTRAOCULAR LENS REPOSITIONING. THE PRODUCT DID NOT CAUSE ANY SERIOUS PATIENT INJURY, THE REPOSITIONING WAS UNCOMPLICATED. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT / DAMAGE. IT WAS FURTHER REPORTED THAT THE RISK OF THE CATARACT SURGERY WAS THE CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16641362 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE CONSUMER CANNOT SEE DISTANCE OR CLOSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED WHICH STATES CONSUMER CALLED REGARDING ISSUE, STATES HAVING DOUBLE VISION, FOCUS IS ABOUT 2-6 FEET. HE STATES SURGEON TOLD HIM THE MANUFACTURER TOLD HIM TO PUT IN ONE EYE FOR DISTANCE AND ONE EYE FOR NEAR. CONSUMER STATES HE HAD ADDITIONAL SURGERY ON LEFT EYE - DUE TO CLOUDING OF VISION ABOUT A WEEK AFTER SURGERY. SURGEON HAS TRIED MULTIPLE PAIRS OF GLASSES. SURGEON WAS PLANNING ON "LASER" AND NOW STATES HE IS NOT GOING TO ANY ADDITIONAL PROCEDURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE 2 FILES ASSOCIATED WITH THESE EVENTS. THIS IS FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 14285483 ↗
• MalfunctionApr 8, 2022Crack; Crack

  A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION WHEN THE LENS WAS INSERTED ABOUT 1/3RD INTO THE EYE A CRACK WAS NOTICED ON THE LENS AND THE END OF THE LENS JUST BROKE OFF AND FELL INTO THE EYE. THE BROKEN PIECES OF THE LENS WERE REMOVED FROM THE EYE IN THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14052426 ↗
• MalfunctionMar 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED FLUCTUATING VISUAL POSTOPERATIVE RESULT WITH GREATER RESIDUAL ASTIGMATISM. ADDITIONAL INFORMATION WAS RECEIVED STATING RESIDUAL CYLINDER WAS REVEALED POSTOPERATIVELY. LENS WAS NOT SITTING PROPERLY. IOL HAS ROTATED IN THE EYE AFTER IMPLANTATION AND WAS NO LONGER IN THE IMPLANTATION AXIS. THE RE-ROTATION OF THE IOL WAS PLANNED. THE VISUAL ACUITY OF THE PATIENT WAS GOOD. THE IOL REMAINS IN THE EYE AND WILL NOT BE EXCHANGED.

  Patient problems: Visual Impairment

  MAUDE report 13937962 ↗
• MalfunctionMar 5, 2021Scratched Material; Scratched Material

  A NURSE REPORTED THAT A MARK WAS OBSERVED ON AN INTRAOCULAR LENS (IOL) EDGE AROUND MID POINT BETWEEN THE HAPTICS AFTER IT WAS IMPLANTED. THE LENS WAS NOT EXPLANTED AS IT WAS ON THE LENS EDGE AND NOT LIKELY TO INFLUENCE THE PATIENT'S VISUAL ACUITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423939 ↗