AcrySof™ IQ Vivity™ DAT015 (REF DAT015.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00380652424691), received between Mar 30, 2021 and Jul 22, 2025 — classified as 17 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2025Product Quality Problem; Product Quality Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HE WAS EXTREMELY DISAPPOINTED AND STATED THE LENS NEVER WORKED, AS HE HAD EXPERIENCED LOSS OF VISION IN HIS RIGHT EYE (ALSO STATED DOUBLE VISION, BLURRY VISION, CLOUDY VISION AND INFECTION) SINCE THE DAY OF SURGERY. THE CONSUMER REPORTED THAT, THE SURGEON REFERRED 2 OTHER DOCTORS AND THEY AGREED THAT HIS EYESIGHT WAS TERRIBLY DISTORTED AND IN FACT HE COULD NOT SEE AND GLASSES WOULD NOT HELP. AFTER THE SURGERY HE WENT TO 3 OTHER INDEPENDENT DOCTORS WHO SAID THE OPERATION LOOKS GOOD, BUT THE LENS FAILED. THE CONSUMER CONTACTED HOSPITAL AND THEIR INSURANCE COMPANY AND CAME BACK WITH A LETTER ON (B)(6) 2025, FROM AN EXPERT THAT READ ALL MEDICAL RECORDS AND CLEARED BOTH HOSPITAL AND SURGEON OF ANY WRONG DOINGS IN THE OPERATION. THE CONSUMER MENTIONED AT THIS POINT HE REALIZED LOSS OF VISION WAS CAUSED BY COMPANY LENS AND NOT THE DOCTOR ERROR. THE CONSUMER ALSO STATES HE EXPERIENCED DIFFICULTIES DAILY AND CANNOT SEE OUT OF HIS RIGHT EYE AND WANT TO BE COMPENSATED, HE CANNOT DRIVE OR PLAY GOLF OR DO NORMAL THINGS AS HE USUALLY DOES. HE STATES COMPANY LENS HAS CHANGED HIS LIFE, AND HE IS DISAPPOINTED IMMENSELY.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Eye Infections; Visual Impairment

  MAUDE report 22566037 ↗
• 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 LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20198450 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT SEE TEN IMAGES WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE PATIENT VISION MISTAKES HAVE NOT BEEN CORRECTED YET AND IMPACTS THE PHYSICAL AND MENTAL HEALTH. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Impairment

  MAUDE report 19087611 ↗
• MalfunctionDec 19, 2023Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON NOTICED SCRATCHES ON THE LENSES. THE IOL LIKELY BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18354274 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 16944290 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED BLURRY VISION CLOSE UP, MID RANGE AND FOR DISTANCE. THEY COULD ONLY GET HIM TO 20/40 VISION WITH A HARD LENS OVER IT. LENS DID NOT WORK FOR HIM AND NOT CORRECTED BY GLASSES. HENCE LENS WAS REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. HE COULD SEE MUCH BETTER AS OF NOW. ADDITIONAL INFORMATION WAS RECEIVED STATING UNSATISFACTORY UCVA. AS PER SURGEON¿S OPINION, PRODUCT OPTICS AND PATIENT HISTORY OF LASIK CAUSED THE EVENT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16310854 ↗
• InjuryNov 1, 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 BLURRY VISION. THE CLINICAL REASON WAS REFRACTIVE ERROR. THE IOL WAS EXPLANTED AND EXCHANGED IN A SECONDARY PROCEDURE FOR A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT PATIENT HAD BLURRED VISION AT ALL DISTANCES AND HAD THE TROUBLE WITH ADAPTATION TO THE MULTI FOCAL LENS. THERE WAS NO PATIENT HARM. THE SURGEON PROGNOSIS WAS GOOD, THE PATIENT WAS NOT HOSPITALIZED AND THE ISSUE HAS BEEN RESOLVED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15710055 ↗
• InjuryOct 6, 2022Adverse 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 DECREASED VISION. ADDITIONAL INFORMATION RECEIVED STATED THAT NOT EXPERIENCING OPTIMUM BEST-CORRECTED VISUAL ACUITY. ONE DAY AFTER SURGERY PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND STEROIDS FOR THE TREATMENT OF EDEMA AND INFLAMMATION. ONE WEEK AFTER SURGERY PATIENT WAS PRESCRIBED WITH ANTIMICROBIAL AND CORTICOSTEROIDS. PATIENT ALSO HAD A HISTORY OF DOUBLE VISION AND GLARE WHILE DRIVING AT NIGHT AND THERE WAS A LONG INCISION AT 021 DEGREE AT THE TIME OF SURGERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; Corneal Edema; Inflammation

  MAUDE report 15557715 ↗
• InjurySep 20, 2022Adverse 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 DECREASED VISION. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT NOT EXPERIENCING OPTIMUM BEST-CORRECTED VISUAL ACUITY. ONE DAY AFTER SURGERY PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND STEROIDS FOR THE TREATMENT OF EDEMA AND INFLAMMATION. ONE WEEK AFTER SURGERY PATIENT WAS PRESCRIBED WITH ANTIMICROBIAL AND CORTICOSTEROIDS. PATIENT ALSO HAD A HISTORY OF DOUBLE VISION AND GLARE WHILE DRIVING AT NIGHT AND THERE WAS A LONG INCISION AT 021 DEGREE AT THE TIME OF SURGERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; Corneal Edema; Inflammation

  MAUDE report 15457768 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING VERTIGO/DIZZINESS WITH LENS. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS VERTICAL DIPLOPIA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Vertigo; Visual Impairment

  MAUDE report 14831748 ↗
• InjuryMay 25, 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 BLURRED VISION, HALOS AND POOR VISION. THE LENS WAS EXCHANGED LATER IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 14495537 ↗
• MalfunctionMar 8, 2022Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THERE WAS SCRATCH ON THE LENS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13692818 ↗
• InjuryFeb 15, 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 HALOS WHILE DRIVING AT NIGHT AND VISION WAS WORSE, NEEDED STRONGER BIFOCAL GLASSES. THE ASTIGMATISM WAS WORSENED AND NO LONGER READ HIS PHONE WITHOUT GLASSES. TWO YAG SURGERIES WERE PERFORMED TO HELP IMPROVE HIS VISION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 13535951 ↗
• InjuryJan 3, 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 DECREASED VISUAL ACUITY AND WAS UNABLE TO READ. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL 49 DAYS FOLLOWING THE INITIAL PROCEDURE. INCONSISTENT RESULT SECOND TO RADIAL KERATOTOMY WAS THE CLINICAL REASON MENTIONED. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Visual Disturbances

  MAUDE report 13142550 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT BLURRY VISION WAS WORSE AFTER CATARACT SURGERY AND CONTRAST SENSITIVITY DECREASED. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12880446 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO PATIENT HARM AND HOSPITALIZATION. POSTOPERATIVE THE PATIENT STOPPED TAKING KETOROLAC AND USED ARTIFICIAL TEARS FREQUENTLY.

  Patient problems: Blurred Vision

  MAUDE report 12517994 ↗
• InjuryAug 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED BLURRY VISION. THE CLINICAL REASON WAS RESIDUAL MYOPIA WITH DECENTERED IOL. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision

  MAUDE report 12341200 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED EXPLANTATION OF AN INTRAOCULAR LENS WITH A PATIENT REASON FOR EXPLANT OF "BLURRED VISION." THE PATIENT WAS DISSATISFIED WITH HIS VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

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

  MAUDE report 11754014 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS WAS EXPLANTED DUE TO IMPROPER POWER. THE PATIENT REPORTED BLURRED VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision

  MAUDE report 11588496 ↗