AcrySof™ IQ Vivity™ DAT415 (REF DAT415.180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652427876), received between Apr 13, 2021 and Aug 30, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Application Program Problem: Power Calculation Error” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Adverse 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, THE PATIENT EXPERIENCED PHOTOPSIA AND STRONG FIGURING. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PROBLEMS WITH SEEING LETTERINGS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17650257 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POSITIVE DYSPHOTOPSIA, DISSATISFACTION WITH QUALITY OF VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON WAS GIVEN AS PARACENTRAL POSITIVE DYSPHOTOPSIA AND INDUCED ASTIGMATISM. ADDITIONAL INFORMATION WAS RECEIVED THAT, THERE WAS NO PATIENT'S HARM INVOLVED. THE PATIENT WAS NOT HOSPITALIZED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 14831448 ↗
• InjuryJun 13, 2022Optical Decentration; Optical Decentration

  A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS DECENTERED IN THE EYE WHICH RESULTS IN DECREASED VISION, IMAGES LOOK UNDERWATER. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED INDICATING THAT THE ACTUAL DATE THE ISSUE WAS OBSERVED. IT WAS ALSO REPORTED THAT IN THE SURGEON'S OPINION, THE LENS DID NOT CONTRIBUTE TO EVENT; THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT¿S ¿PHIMOSIS.¿ THE ORIGINALLY SCHEDULED PROCEDURE WAS COMPLETED THE SAME DAY. THERE WAS NO PATIENT HARM

  Patient problems: Visual Impairment

  MAUDE report 14674205 ↗
• InjuryApr 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE LENS HAD ROTATED SLIGHTLY AND A LASIK HAD TO BE PERFORMED. PATIENT HAD EXPERIENCED NEAR VISION WAS NOT CLEAR AND HAD FLASHES, FLICKERING ALONG WITH AN RISE IN THE INTRAOCULAR PRESSURE. THE PATIENT HAD ALSO EXPERIENCED SYMPTOMS SUCH AS WATERY EYE, DRY EYE AND WAS ALSO OUT OF FOCUS.

  Patient problems: Blurred Vision; Dry Eye(s); Excessive Tear Production; Intraocular Pressure Increased; Visual Disturbances

  MAUDE report 14136129 ↗
• InjuryMar 21, 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 EXPERIENCED CLOUDY VISION AND WAS NOT ABLE TO ADAPT TO THE LENS. THE LENS WAS EXCHANGED LATER IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 13840247 ↗
• InjuryFeb 8, 2022Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION AFTER CATARACT SURGERY. CLINICAL REASON INCORRECT IOL POWER. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 8 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Visual Disturbances

  MAUDE report 13480796 ↗
• InjuryApr 13, 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, A REFRACTIVE ERROR OCCURRED. THE IOL WAS EXCHANGED APPROXIMATELY TWO WEEKS AFTER THE INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 11658188 ↗