ACRYSOF® IQ RESTOR® SN6AD1 (UDI 00380652241502)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC. · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652241502), received between Sep 15, 2021 and Sep 15, 2021 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blurred Vision2
- Halo2
- Visual Disturbances2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IOL IMPLANT PROCEDURE, THE PATIENT COMPLAINT OF DECREASED QUALITY OF VISION, GLARE, HALOS AT NIGHT AND OVERALL WAS VERY UNHAPPY WITH HER VISION. THE LENS WAS LATER EXPLANTED IN A SECONDARY PROCEDURE. HER DISTANCE VISION HAS IMPROVED NOW. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PROGNOSIS WAS GOOD AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 12477212 ↗InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT¿S QUALITY OF VISION WAS DECREASED. THE PATIENT EXPERIENCED GLARE, HALOS AT NIGHT AND WAS UNHAPPY. THE IOL WAS EXCHANGED WITH AN ANOTHER MODEL IOL, 4207 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. DISTANCE VISION WAS BLURRY HOWEVER IT WAS IMPROVED. NO FURTHER INFORMATION IS EXPECTED.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 12473740 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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