AcrySof™ IQ Vivity™ DFT015 (REF DFT015.160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652421157), received between Apr 26, 2021 and Mar 18, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Material Opacification; Material Deformation

  A PHYSICIAN REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS HAD GLISTENING AND OPACIFICATION AND THE PATIENT EXPERIENCED BLURRED VISION. HENCE THE PHYSICIAN HAS PLANNED TO EXPLANT THE LENS IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision

  MAUDE report 24629600 ↗
• MalfunctionFeb 21, 2026Failure to Fold; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, IT WAS NOT POSSIBLE TO CORRECTLY IMPLANT THE LENS. THE ISSUE WAS RELATED TO THE IOL ITSELF, WHICH APPEARED EXTREMELY RIGID FROM THE BEGINNING AND BECAME STUCK INSIDE THE CARTRIDGE IMMEDIATELY. DUE TO THE RIGIDITY OF THE LENS, IT WAS NOT POSSIBLE TO EXTRACT IT OR REINSERT IT TO ATTEMPT A NEW IMPLANTATION. CONSEQUENTLY, A BACKUP LENS OF SAME MODEL BUT HALF A DIOPTER LESS POWER WAS USED TO COMPLETE THE SURGERY ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24408636 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED IN SECONDARY PROCEDURE DUE TO REFRACTIVE ERROR, HEADACHE, TREMOR. PATIENTS SYMPTOMS RESOLVED AFTER LENS EXCHANGE. ADDITIONAL INFORMATION WAS REQUESTED. PRE-OP MEASUREMENTS: BCVA (INCLUDE DATE): 26-JUN-2024 -8.25 / -0.5 / 31 DEGREE /1.0 MRX (INCLUDE DATE): -6.50 /-0.25 / 2 / 1.0 ON 26-APR-2024 PREVIOUS CONTACT LENS USE WITHIN THE LAST YEAR: NO. POST-OP MEASUREMENTS: UCVA (INCLUDE DATE): 1.0 BCVA (INCLUDE DATE): 1.2 MRX (INCLUDE DATE): +0.75 / -0.50 / 61 DEGREE ON 22-NOV-2024.

  Patient problems: Headache; Shaking/Tremors; Visual Impairment

  MAUDE report 21068303 ↗
• InjuryOct 31, 2023Malposition of Device; Malposition of Device

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS HAD TO BE REMOVED DUE TO DISLOCATION WITHIN THE CAPSULE AND A SLIGHT RESIDUAL DEFECT. THE LENS WAS EXPLANTED AND REPLACED WITH COMPANY LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 18038806 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING DAY OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SEVERE INFLAMMATORY RESPONSE, EXUDATIVE MEMBRANE AROUND IOL, FUNDUS GLOW SEE HAZY. SECOND FOLLOW-UP ON (B)(6)-SITUATION WAS WORSEN, FUNDUS NOT SEEN, SEVERE EXUDATION AROUND IOL IN SPITE OF STEROIDS AND CYCLOPLEGICS. THE PATIENT HAD CONJUNCTIVAL INFLAMMATION, AQUEOUS CELL +2, AQUEOUS FIBRIN-PRESENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Inflammation

  MAUDE report 17458871 ↗
• InjuryOct 19, 2022Defective Component; Device Dislodged or Dislocated; Defective Component; Device Dislodged or Dislocated

  A NON HEALTH CARE PROFESSIONAL REPORTED FOLLOWING IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED CLOUDY VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND THERE WAS A QUALITY ISSUE WITH THE LENS THAT CAUSED OR CONTRIBUTED TO THE EVENT INDICATING LENS NOT CENTERED, POSSIBLE DAMAGE TO HAPTIC. THE LENS WAS EXCHANGED WITH ANOTHER LENS MODEL.

  Patient problems: Visual Disturbances

  MAUDE report 15632302 ↗
• InjuryJul 15, 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 EXPERIENCED EYE PAIN, INFLAMMATION AND ALSO SAID THAT IT LOOKS LIKE ENDOPHTHALMITIS AT THE HOSPITAL. THE DOCTOR HAD PRESCRIBED THE ANTIBIOTICS AS A TREATMENT AND PATIENT WAS UNDER OBSERVATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Endophthalmitis; Eye Pain; Inflammation

  MAUDE report 12173670 ↗
• MalfunctionApr 26, 2021Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INSERTION OF AN INTRAOCULAR LENS (IOL) INTO AN EYE A SHAVING FROM THE EDGE OF THE OPTIC WAS NOTED. THE SURGEON CLIPPED IT OFF WITH MICRO SCISSORS. THE LENS REMAINS IMPLANTED WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11726356 ↗