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ACRYSOF, IQ RESTOR SND1T4 (REF SND1T4U225)Recalls & reported problems

Alcon Laboratories, Inc. · Acrysof IQ ReStor Multifocal Toric IOL, STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 2.58 · Class 3 · Implant

All models of ACRYSOF IQ RESTOR (34)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652270670), received between Jul 9, 2021 and Jul 9, 2021 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Halo1
  • Unspecified Eye / Vision Problem1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 9, 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 HAD HALOS AT NIGHT. THE IOL WAS EXCHANGED FOR ANOTHER LENS AFTER 1 YEAR FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON GIVEN FOR THE EXPLANT WAS ¿UNHAPPY WITH VISION.¿ ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Halo; Unspecified Eye / Vision Problem

    MAUDE report 12141895 ↗

Other LENS, MULTIFOCAL INTRAOCULAR devices

All LENS, MULTIFOCAL INTRAOCULAR devices →

Sources and updates

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