AcrySof™ IQ Vivity™ DAT015 (REF DAT015.195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380652424622), received between May 11, 2021 and Sep 12, 2024 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2024Adverse 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 MALADAPTATION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20206183 ↗
• InjuryJun 12, 2024Adverse 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 VISION WAS BLURRY AND IN SURGEONS PROGNOSIS IT WAS NON-ADAPTATION TO A MULTI-FOCAL IOL, MECHANICAL COMPLICATION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 21 DAYS FOLLOWING THE INITIAL PROCEDURE. THERE WAS NO PATIENT HARM AND THE PATIENT ISSUES WERE RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19524691 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER SURGERY, PATIENT WAS UNHAPPY WITH THE INTERMEDIATE VISION WITH THESE LENSES, CANNOT READ PHONE. SHE HAD SURGERY ABOUT A YEAR AGO AND HAD NOT IMPROVED. SHE FELT LIKE SHE WAS MISLED BY THE MARKETING THAT SHE WOULD BE ABLE TO SEE ALL DISTANCES WITHOUT GLASSES. SHE HAS HAD A YAG LASER OS (B)(6) 2023. SHE WILL HAVE THE FELLOW EYE YAG LASER NEXT WEEK. SHE WAS TOLD MAYBE LASIK WOULD IMPROVE HER VISION. SHE DID NOT WANT ANY FURTHER SURGERY. HER DISTANCE VISION WAS VERY GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT VISION NOT IMPROVED SINCE YAG LASER. THE SURGEON WHO DID HER LASER WAS NOT THE SURGEON WHO DID HER CATARACT SURGERY. HE NO LONGER WORKS THERE. SHE WAS NOT GOING TO HAVE AN EXPLANT. SHE WILL CALL BACK IN 90 DAYS TO GET THE FINAL RESULT OF INVESTIGATION. ALSO, IT WAS STATED THAT THE THIS LENS DOES NOT PROVIDE ADEQUATE NEAR VISION. PATIENT DID NOT UNDERSTAND THIS AND LENS DID NOT MEET EXPECTATIONS OF PATIENT.

  Patient problems: Blurred Vision

  MAUDE report 17823530 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DYSPHOTOPSIA. THE LENS WAS EXPLANTED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS HALOS AT NIGHT, DECREASED VISION OVERTIME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo; Visual Impairment

  MAUDE report 16511699 ↗
• InjuryDec 2, 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 WAS NOT SEEING THE BENEFITS OF THE LENS, THE CLINICAL REASON WAS MECHANICAL COMPILATION. THE IOL WAS EXPLANTED AND EXCHANGED WITH MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 15904451 ↗
• InjuryNov 25, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A DOCTOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION BLURRY AND GLARE. EXPLANTED IOL WITH REASON ANISOMETROPIA, POST-OPERATIVE REFRACTION 1 DIOPTER MORE MYOPIC THAN PLANNED/EXPECTED BASED ON IOL MASTER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT SURGEON REPORTS AT 6 WEEKS POST OP WAS ONE DIOPTER MORE AT POST OP THAN INTENDED/PREDICTED ON IOL MASTER SCANS. LENS WAS CENTERED POST OP. SUSPECT POSSIBLE MISLABELED LENS. REFRACTIVE ERROR RESULTED IN ADDITIONAL SURGERY(LENS EXCHANGE) INTRAOPERATIVE FLOPPY IRIS SYNDROME WAS ENCOUNTERED DURING THE RE-OPERATION WHICH MADE THE EXCHANGE SURGERY CHALLENGING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment

  MAUDE report 15864711 ↗
• InjuryOct 14, 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 (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NO CLEAR VISION AT ANY DISTANCE, NOT EVEN WITH READING GLASSES, HAZY, BLURRED, STARBURST AT NIGHT AND DARK AREAS. NO ACUITY AT ANY DISTANCE, FOGGY, THROUGH WATER APPEARANCE NO FOCUS AND IT WAS A MAJOR DISAPPOINTMENT. PATIENT HAD DISCUSSED NUMEROUS TIMES WITH EYE CARE PROVIDER AND RECEIVED YAG SURGERY WITH NO IMPROVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING DARK SPORT IN HIS RIGHT EYE VISION WHILE MOVING EYE, NEGATIVE DYSPHOTOPSIA AND FOGGY VISION AT ALL DISTANCES.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15603112 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE DISTANCE VISION BEYOND AROUND 18¿ IS STILL FUZZY AS WELL AS CLOSEUP. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING LENS GET DRY DURING AWAKENING HOURS, BUT AFTER USE OF REFRESH ON A REGULAR BASIS WHICH HELPS FOR A WHILE. COMPUTER SCREENS AT ABOUT 31¿ BEGINS TO GET IN THE FUZZY ZONE & THERE ON OUT, MY VISION IS FUZZY AND NOT BEING ABLE TO RECOGNIZE PEOPLE FROM ABOUT 20+ FEET OUT IS SOMEWHAT FRUSTRATING. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING EXPERIENCING LITTLE HAZE 2 MONTHS AGO & SAID IF IT¿S STILL THERE. OPHTHALMOLOGIST CAN FIX IT WITH LASER SURGERY, BUT HE ALSO SAID THAT COULD AFFECT THE VISION PROCESS. THE PATIENT WAIT UNTIL AROUND DECEMBER SINCE RIGHT EYE WAS DONE JUNE 9TH. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Dry Eye(s)

  MAUDE report 15247294 ↗
• InjuryJul 18, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A REGISTERED NURSE REPORTED THAT APPROXIMATELY AFTER 5 MONTHS OF IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE LENS WAS EXPLANTED WITH A PATIENT REASON OF BLURRY VISION AND A CLINICAL REASON OF WRONG POWER AND MECHANICAL COMPLICATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15040418 ↗
• InjuryJul 14, 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 EXPERIENCED HAZINESS, FILM, NOT CLEAR AND BLURRED VISION. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE FOR ANOTHER LENS. THE CLINICAL REASON FOR EXPLANT WAS VISUAL DISCOMFORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Discomfort; Visual Impairment

  MAUDE report 15010868 ↗
• InjuryMay 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS EXPLANTED DUE TO INSUFFICIENT POWER, RESIDUAL ASTIGMATISM. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH ANOTHER LENS MODEL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14398604 ↗
• 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 HAD POOR BEST CORRECTION, VISUAL ADDING. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS POOR VISION CORRECTION. ADDITIONAL INFORMATION AHS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 14338920 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED GLARE AND HALOS. THE PATIENT WAS UNABLE TO DRIVE AT NIGHT DUE TO THE GLARE. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13385122 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANTATION AFTER A MONTH THE LENS WAS EXPLANTED DUE TO POOR DISTANCE VISUAL QUALITY AND CONTRAST DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 11871584 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED POOR DISTANCE VISION AND WANTED IT TO BE BETTER, UNINTENDED MYOPIA. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS DURING SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 11849747 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED BLURRED VISION AT ALL DISTANCES, AND WAS UNABLE TO READ AT ALL NEAR OR INTERMEDIATE. LENS WAS EXCHANGED WITH A DIFFERENT ONES DURING SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED REPORTING IN THE SURGEON¿S OPINION, THE PRODUCT CAUSED THE EVENT. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 11805401 ↗