AcrySof™ IQ Vivity™ DFT515 (REF DFT515.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652422475), received between Jan 11, 2023 and Jan 14, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF SCRATCHES WAS FOUND ON INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24068376 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD HAD A VISUAL ACUITY OF 5/10 AND AN ASTIGMATISM OF 2 AT DAY 3 OF POST-OPERATION. THE SURGEON CHECKED THE IMPLANT CENTERING AND THE BIOMETER CALCULATIONS AND THERE IS NOTHING TO REPORT FROM THESE. ON DAY 10, THE PATIENT WAS STILL AT 5/10, SO THE SURGEON EXCHANGED WITH NON-COMPANY IOL. THE PATIENT AND WANTED US TO ANALYZE THE LENS TO SEE IF THE IMPLANT HAD THE RIGHT POWER, I.E. +20.5 DIOPTERS. ADDITIONAL INFORMATION RECEIVED AND STATED AT DAY 3 VA WAS 6/10 SC WITH A LITTLE EDEMA ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Edema; Visual Impairment

  MAUDE report 17920003 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT AFTER CATARACT SURGERY PATIENT EXPERIENCED WITH SEVERE ENDOPHTHALMITIS OR TOXIC ANTERIOR SEGMENT SYNDROME WITH FUNCTIONAL LOSS OF EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A PATIENT UNDERWENT CATARACT SURGERY WITH IOL IMPLANTATION IN RIGHT EYE WITH MEDICAL HISTORY OF NON-INSULIN DEPENDENT DIABETES (WELL-BALANCED). AFTER NINE DAYS OF SURGERY THE PATIENT EXPERIENCED WITH SEVERE ENDOPHTHALMITIS WITH LOSS OF FUNCTION OF THE EYE, CONJUNCTIVAL INFLAMMATION: 3+, CELLS IN THE ANTERIOR CHAMBER: 3+, FIBRIN IN THE ANTERIOR CHAMBER, HYPOPYON WITH SIGNS AND SYMPTOMS OF PAIN, EDEMA OF THE UPPER EYELID, CYCLITIC MEMBRANE PREVENTING EXAMINATION OF THE VITREOUS. PATIENT WAS ADMITTED IN HOSPITAL TREATED WITH SUBCONJUNCTIVAL INJECTION, INTRAVITREOUS INJECTION OF ANTIBIOTICS, GLUCOCORTICOID INJECTION, INTRAVITREOUS INJECTION OF GLUCOCORTICOID, STEROID IN SUBCONJUNCTIVAL FORM. ADMINISTERED MEDICATION WAS NOT EFFECTIVE AND PATIENT SYMPTOMS WERE NOT RESOLVED AND PURULENT MELTING OF THE EYE. THIS EVENT LEADS TO TOTAL LOSS OF VISUAL FUNCTION AND RISK OF PURULENT MELTING. NEW INFORMATION RECEIVED INDICATING VISCOELASTIC, BALANCED SALT SOLUTION AND INTRAOCULAR LENS ALSO A SUSPE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Endophthalmitis; Eye Pain; Hypopyon; Inflammation; Loss of Vision; Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 16136282 ↗