ACRYSOF® IQ RESTOR® SN6AD1 (UDI 00380652241601)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
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 00380652241601), received between Jul 17, 2023 and Jul 17, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Material Opacification” (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.
Most reported problems
Device problems
- Material Opacification1
Patient problems
- Blurred Vision1
- Inflammation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2023Material Opacification; Material Opacification
A PHYSICIAN REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRINESS TO ONE EYE. THE EXAMINATION SHOWS, A SUPERFICIAL, SWIRLING, VERY THIN LAYER OF SOMETHING OPAQUE ON THE LENS. THE PATIENT ALSO HAVE ADVANCED RENAL CANCER AND IS ON CHEMO. PRED AND PROLENSA SEEM TO HAVE NO EFFECT. SO THE PHYSICIAN DOUBT IT TO BE INFLAMMATORY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PATIENT HAD DEVELOPED MILKY SWIRLING SUPERFICIAL DEPOSITION OF SOME SORT. A YAG SURGERY WAS PERFORMED AND NOTHING WORKED. THE DOCTOR IS TRYING RESTASIS NOW. THE DOCTOR DOUBTS THAT IF IT IS RELATED TO ANY MATERIAL ISSUE, THE NATURE IS OF A DEPOSITION OF SOMETHING.
Patient problems: Blurred Vision; Inflammation
MAUDE report 17331477 ↗
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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