ACRYSOF, IQ RESTOR SND1T3Recalls & 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 1.50 · Class 3 · Implant
All models of ACRYSOF IQ RESTOR (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652269094), received between Jun 6, 2022 and Dec 5, 2024 — classified as 1 injury, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device1
- Malposition of Device1
Patient problems
- Insufficient Information1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2024Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, DAMAGED INTRA OCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20855576 ↗InjuryJun 6, 2022Malposition of Device; Malposition of Device
AN ACCOUNTS PAYABLE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED 5 YEARS AFTER IMPLANTATION DUE TO DISTORTED VISION AND SUBLUXATION OF LENS. THE LENS WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Disturbances
MAUDE report 14601449 ↗
Other LENS, MULTIFOCAL INTRAOCULAR devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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