ACRYSOF® RESTOR® SV25T0 (UDI 00380652307765)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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652307765), received between Jul 7, 2021 and Feb 12, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Particulates” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Particulates1
Patient problems
- Visual Disturbances3
- Halo1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2026Particulates
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD HALOS AND GLARE. THE LENS WAS EXCHANGED WITH COMPANY DIFFERENT LENS TYPE AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS INCLUSIONS IN IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 24329574 ↗MalfunctionNov 8, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED OF GLISTENINGS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT PATIENT WAS NOT HAPPY, IT SEEMS LIKE LOOKING UNDERWATER WAS ABLE TO READ J3 UNAIDED AND ENJOYED GOOD NEAR VISION. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Visual Disturbances
MAUDE report 15751724 ↗InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A OPHTHALMIC SURGEON REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT IS EXPERIENCED GLARES AND HALOS AROUND LETTERS WHEN READING SIGNS WHILE DRIVING. SHE ALSO REPORTS SEEING A GRAY OUTLINE AROUND LETTERS. PATIENT HAS NOTICED AN IMPROVEMENT SINCE HER 1 WEEK POST OPERATION VISIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT THE SURGERY OCCURRED ON 27 APR 2022. VISCOELASTIC WAS USED TO EXPAND THE CAPSULE AND FLOAT THE INTRAOCULAR LENS INTO THE ANTERIOR CHAMBERS. THE LENS WAS CUT IN HALF USING FORCEPS AND SCISSORS. EYE DROPS WERE RECOMMENDED. SYMPTOMS WERE RESOLVED.
Patient problems: Halo; Visual Disturbances
MAUDE report 14786420 ↗InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CLINICAL DIRECTOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED UNDESIRED VISUAL QUALITY. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 1 YEAR AND 6 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON GIVEN FOR THE EXPLANT WAS ¿MONOCULAR DIPLOPIA.¿ ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 12131551 ↗
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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