ACRYSOF® RESTOR® SV25T0 (UDI 00380652307727)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652307727), received between Mar 25, 2021 and Jun 7, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED IN A CLINICAL STUDY THAT DURING THE STUDY PATIENT NEVER COMPLAINED OF HALOS, HOWEVER AFTER THE TRIAL WAS COMPLETED NOTED THAT THE PATIENT HAD EXPERIENCED HALOS IN THE LEFT EYE. THE LENS WAS THEN EXCHANGED IN A SECONDARY PROCEDURE WITHOUT ANY COMPLICATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo

  MAUDE report 14618587 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIALLY DYSPHOTOPSIA WAS REPORTED AS WELL.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11566807 ↗