AcrySof™ IQ Vivity™ DFT015 (REF DFT015.165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652421164), received between Sep 30, 2021 and Apr 9, 2026 — classified as 5 injuries, 2 malfunctions.

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

• MalfunctionApr 9, 2026Device Damaged by Another Device

  A PHARMACIST REPORTED THAT PLUNGER DID NOT PASS THROUGH THE INTRAOCULAR LENS (IOL) PROPERLY, RESULTING IN DAMAGE TO THE LENS. THE SURGERY WAS COMPLETED WITH A BACKUP LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24825534 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE REASON FOR THE EXPLANT WAS PATIENT EXPRESSED DISSATISFACTION BECAUSE, DESPITE THE IMPLANTATION OF THE COMPANY LENS, SHE REPORTED INSUFFICIENT VISUAL ACUITY IN THE INTERMEDIATE AND NEAR VISION RANGES. SHE STATED THAT THE RESULT DID NOT MEET HER EXPECTATIONS AND THAT THIS SIGNIFICANTLY IMPAIRED HER QUALITY OF LIFE. SYMPTOMS WERE RESOLVED. THE LENS WAS EXPLANTED AND REPLACED WITH A NON-COMPANY LENS DURING SECONDARY PROCEDURE. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS FOR RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 24333638 ↗
• MalfunctionOct 30, 2024Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAD A HAPTIC RIPPED OFF/ AMPUTATED BY THE INJECTOR. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER UNSPECIFIED LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH PATIENT HARM CORNEAL EDEMA DUE TO EXCESSIVE MANIPULATION OF THE EYE. NO MEDICAL INTERVENTION OR HOSPITALIZATION WAS REQUIRED, AND CURRENT CONDITION OF THE PATIENT WAS IMPROVING. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE PATIENT WAS IN FOR A ONE-WEEK CHECK-UP, WITH RESIDUAL CORNEAL EDEMA, WHICH WAS 80 PERCENT RECOVERED.

  Patient problems: Corneal Edema; Insufficient Information

  MAUDE report 20569886 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CONSUMER EXPERIENCED HALOS AROUND LIGHT DURING DAY AND NIGHT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED STATING PATIENT EXPERIENCED POSTERIOR CAPSULAR OPACIFICATION, THE HALOS DISAPPEARED 80% DURING THE DAY AND 50% AT NIGHT. THE SYMPTOMS STARTED 2 MONTHS AFTER SURGERY. THE SURGEON PRESCRIBED PILOCARPINE TO DECREASE THE SYMPTOMS. NO FURTHER INFORMATION AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

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

  MAUDE report 15238901 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT, FOLLOWING INTRAOCULAR LES (IOL IMPLANT PROCEDURE, THE POSTERIOR CAPSULAR RUPTURE OCCURRED WHEN I/A PERFORMING AFTER THE IOL WAS INSERTED INTO THE CAPSULE BAG. THE LENS WAS REPLACED AND THE PROCEDURE WAS COMPLETED FIXING THE SCLERA. THE LENS WAS CUT IN HALF IN THE EYE AND REMOVED IT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 14495435 ↗
• InjuryJan 5, 2022Adverse 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 DID NOT ABLE TO SEE VERY WELL AT DISTANCE, AND IN 3 FEET CANNOT SEE THINGS SUCH AS TELEPHONE, THE REMOTE CONTROL FOR THE TV, THE COMPUTER SCREEN, OR ANY PRINT SUCH AS BOOKS OR NEWSPAPER. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT HAD A WRINKLES IN THE EYE AND HAD A YAG (YTTRIUM-ALUMINUM-GARNET) SURGERY AND THERE WAS NO IMPROVEMENT NOTICED IN THE NEAR VISION. NO FURTHER INFORMATION AVAILABLE. 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; Blurred Vision

  MAUDE report 13168426 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS DISAPPOINTED WITH VISION, COULD NOT SEE STREET SIGNS, USING MAGS FOR READING, ALSO PATIENT HAD SOME ITCHINESS, DECREASE INTRAOCULAR PRESSURE, SOME OCCASIONAL SPOTS OF LIGHT AND EARLY POSTERIOR CAPSULE OPACIFICATION FRAGMENT DISRUPTION. THE PATIENT UNDERWENT YAG CAPSULOTOMY. THE DOCTOR PRESCRIBED STEROIDAL DROPS AS A TREATMENT TO THE PATIENT. NO MORE INFORMATION AVAILABLE. 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; Blurred Vision; Halo; Intraocular Pressure Decreased; Itching Sensation

  MAUDE report 12557103 ↗