AcrySof™ IQ Vivity™ DFT315 (REF DFT315.175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652421591), received between Jul 30, 2021 and Feb 20, 2024 — classified as 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, THE IMPLANTED LENS HAS AN ERROR OR MANUFACTURING DEFECT WITH RESPECT TO THE DIOPTERS THAT IT CORRECTS OR HAS BEEN CARVED, EITHER IN THE TORIC PART, SPHERICAL OR BOTH. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, LENS IMPLANTED WITH REFRACTIVE RESIDUAL THAT A PRIORI ATTENDS TO ROTATION OF THE LENS. ALSO, THE PATIENT IS NOT SEEING, AND THE RESIDUAL REFRACTION IS -1.25 (+1.50). THERE IS PATIENT IMPACT AND THE PATIENT'S SYMPTOMS IS STILL CONTINUING.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18737112 ↗
• InjuryNov 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT NEAR VISION WAS POOR, REFRACTIVE ERROR/REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15864690 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AT ALL RANGES. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 3 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS UNCORRECTABLE BLURRY VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 13018867 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SYMPTOMS WERE RESOLVED.

  Patient problems: Visual Disturbances

  MAUDE report 12618207 ↗
• InjuryJul 30, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A FACILITY REPRESENTATIVE REPORTED EXPLANTATION OF AN INTRAOCULAR LENS (IOL) DUE TO POOR VISION AND IOL INSTABILITY. A CAPSULAR TEAR OCCURRED AND THE PATIENT EXPERIENCED A RETINAL DETACHMENT DURING THE INITIAL INTRAOCULAR LENS IMPLANT PROCEDURE. RETINAL DETACHMENT REPAIR WAS PERFORMED AND THE IOL WAS EXCHANGED WITH AN ANTERIOR CHAMBER IOL. THE PATIENT HAS SOME MACULAR EDEMA BUT THE PROGNOSIS IS GOOD. THE SURGEON INDICATED THAT THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT; HOWEVER, FURTHER INFORMATION WAS NOT PROVIDED.

  Patient problems: Capsular Bag Tear; Macular Edema; Retinal Detachment; Visual Impairment

  MAUDE report 12255318 ↗