AcrySof™ IQ Vivity™ DAT015 (REF DAT015.180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652424592), received between Jun 1, 2021 and Apr 26, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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.

• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, PATIENT'S VISION WAS NOT AS GOOD AS EXPECTED AND SHE HAD EPIRETINAL MEMBRANE MORE IN THE LEFT EYE THAT THE RIGHT, HAD CYSTOID MACULAR EDEMA WITH VITREOMACULAR TRACTION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

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

  MAUDE report 16814789 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING POOR VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 15201334 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Scratched Material; Adverse Event Without Identified Device or Use Problem; Scratched Material

  A CONSUMER REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, HIS VISION WAS HORRIBLE, DOUBLE/GHOST IMAGE AND CAN BARELY WORK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 14112187 ↗
• InjuryMar 30, 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 WAS NOT HAPPY WITH THE VISION. THE PATIENT WENT TO ANOTHER OPHTHALMOLOGIST FOR A SECOND OPINION AND DOCTOR DID A (YTTRIUM ALUMINUM GARNET) YAG ON THE CAPSULE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT PATIENT DID NOT LIKE THE COMPANY LENS AND STILL HAD THE LENS IN THE EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE 1 OF 2 FILES.

  Patient problems: Visual Disturbances

  MAUDE report 13950062 ↗
• MalfunctionFeb 10, 2022Defective Device; Device Contamination with Chemical or Other Material; Defective Device; Device Contamination with Chemical or Other Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS DEFECTIVE AND CONTAMINATED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13505234 ↗
• InjurySep 22, 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, THE PATIENT VISION WAS NOT ENOUGH FOR READING AND CLINICAL REASON FOR EXPLANT WAS TARGET CHANGE. THE IOL WAS EXCHANGED FOR ANOTHER LENS 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12513239 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS ADDED. THE IOL WAS REPLACED WITH A DIFFERENT IOL DUE TO BLUR EYE POST OPERATION. AS PER THE PHYSICIAN THERE IS NO ABNORMALITY AND SEES NO OBVIOUS ETIOLOGY FOR THE OUTCOME.

  Patient problems: Blurred Vision; Insufficient Information

  MAUDE report 12121524 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT WAS UNABLE ADAPT TO THE LENS. THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 11915517 ↗