ACRYSOF® IQ RESTOR® SN6AD1 (UDI 00380652241670)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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652241670), received between Mar 3, 2021 and Feb 9, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Adverse Event Without Identified Device or Use Problem3
- Device Dislodged or Dislocated1
- Scratched Material1
Patient problems
- Blurred Vision2
- Visual Impairment2
- No Code Available1
- Visual Disturbances1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT A QUALITY ISSUE DID NOT CONTRIBUTE TO THE EVENT. THE LENS WAS MIS POWERED. IT WAS AN INFERIOR DECENTERED W/ PHACODONESIS. NO PATIENT HARM WAS REPORTED.
Patient problems: Visual Impairment
MAUDE report 18675088 ↗InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Blurred Vision
MAUDE report 17150810 ↗InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE, CLOUDINESS AND POOR VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 12691805 ↗InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATES THE PATIENT WAS REFERRED TO THE SURGEON AFTER THE IOL EXCHANGE WITH ANOTHER SURGEON AND NOTED TO LEAVE A ONE PIECE IOL IN THE SULCUS. THE PATIENT HAS IRIS TRANSILLUMINATING DEFECT IN THE LEFT EYE WHICH IS STABLE AND THE PATIENT PROGNOSIS IS STABLE.
Patient problems: No Code Available
MAUDE report 11405625 ↗InjuryMar 3, 2021Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS NOTED TO BE DAMAGED AND ABNORMAL. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATES THE PATIENT'S PROGNOSIS IS FAIR POST IOL EXCHANGE. THE IOL WAS NOTED TO HAVE A SCRATCH ON OPTIC IN VISUAL AXIS AND THE PATIENT NOTED BLURRY VISION.
Patient problems: Blurred Vision
MAUDE report 11405609 ↗
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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