AcrySof™ IQ Vivity™ DFT315 (REF DFT315.160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652421560), received between Sep 30, 2021 and Apr 25, 2025 — classified as 4 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED DISTANCE VISION IMPROVED, READING ABILITY WAS LIMITED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING PATIENT SYMPTOMS WERE STILL CONTINUING USING GLASSES TO READ.

  Patient problems: Blurred Vision

  MAUDE report 21907889 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT ENCOUNTERED IMAGE DISTORTION WITHIN THE OPTICAL CENTER OF THE EYE. THIS DISTORTION MANIFESTED AS A HORIZONTAL STRIP THAT APPEARED SHIFTED TOWARDS THE RIGHT. NOTABLY, THIS DISTORTION WAS LOCALIZED EXCLUSIVELY TO THE CENTRAL AREA OF THE PATIENT'S VISUAL FIELD. LEFT EYE STATUS NOTED TO BE CORNEA CLEAR, ANTERIOR CHAMBER OF MEDIUM DEPTH, MOISTURE CLEAR, PUPIL DIAMETER 3.5 MM UNDER NATURAL LIGHT CONDITIONS. REACTION TO LIGHT - 3RD DEGREE, WITH MYDRIASIS, THE PUPIL EXPANDS TO 8 MM. THE POSITION OF THE IOL IN THE CAPSULAR BAG WAS CORRECT, THE IOL WAS POSITIONED ALONG THE STRONG MERIDIAN (90 DEGREES) ACCORDING TO THE PREOPERATIVE MARKING. THERE WAS NO ROTATION ANGLE AFTER THE OPERATION. THE PATIENT UNDERWENT LASER CAPSULOTOMY OF THE POSTERIOR CAPSULE; COMPLAINTS OF DISTORTION IN THE CENTRAL ZONE IN THE FORM OF A STRIP WITH DID NOT DISAPPEAR. IN THE POSTERIOR CAPSULE, THE DISSECTIONAL OPENING WAS 4.5 MM. THE REFLEX WAS PINK, THE VITREOUS BODY WAS TRANSPARENT, THE DISK WAS PALE PINK, THE BOUNDARIES WERE CLEAR, MACULAR REFLEXES WERE NOT CHANGED, FOCAL CHANGES IN THE RETINA WERE NOT DETECTED. THE IOL WAS DEC

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

  MAUDE report 17660454 ↗
• InjuryAug 25, 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, BLURRY VISION AND DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS PROVIDED THAT THE IOL WAS EXCHANGED WITH ANOTHER LENS IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15293296 ↗
• 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, FRAGMENT DISRUPTION, DECREASE INTRAOCULAR PRESSURE AND SOME OCCASIONAL SPOTS OF LIGHT. THE DOCTOR PRESCRIBED STEROIDAL DROPS AS A TREATMENT TO THE PATIENT. EARLY POSTERIOR CAPSULE OPACIFICATION (PCO) WAS ALSO REPORTED. THE PATIENT UNDERWENT YAG CAPSULOTOMY. NO MORE 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; Blurred Vision; Halo; Intraocular Pressure Decreased; Itching Sensation

  MAUDE report 12557678 ↗