ACRYSOF RESTORRecalls & reported problems across all models
Alcon Laboratories, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 0
We found 14 models of ACRYSOF RESTOR by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Mar 17, 2021 and Feb 12, 2026 — classified as 20 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ACRYSOF RESTOR problems
Device problems
- Adverse Event Without Identified Device or Use Problem18
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Mechanical Problem1
- Particulates1
- Scratched Material1
Patient problems
- Visual Disturbances9
- Visual Impairment8
- Halo6
- Blurred Vision3
- Endophthalmitis3
- Corneal Edema2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
ACRYSOF RESTOR models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR4 reports
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR3 reports
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR3 reports
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR2 reports
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR2 reports
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® RESTOR® SV25T0LENS, MULTIFOCAL INTRAOCULAR1 report
Recent ACRYSOF RESTOR adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION AND GLARE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS PHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 18730142 ↗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 ↗InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR UNCORRECTED AND BEST CORRECTED VISION AND THERE WAS NO IMPROVEMENT WITH THE LUBRICATION THERAPY. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT PATIENT UNDERWENT INTRA OCULAR LENS (IOL) EXCHANGE FOR MONOFOCAL IOL IN THE RIGHT EYE. ONE DAY AFTER SURGERY THE NEW IOL APPEARED CENTERED AND STABLE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 15569160 ↗InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN HEALTHCARE PROFESSIONAL REPORTED THAT IN A STUDY, AFTER INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE STUDY PATIENT EXPERIENCED AN INABILITY TO SEE WELL POSTOPERATIVELY WITH THE LENSES. THE IOLS WERE REMOVED DURING THE SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS NOT REQUESTED DUE TO LACK OF REPORTER CONTACT INFORMATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR 1ST EYE.
Patient problems: Visual Impairment
MAUDE report 15500909 ↗InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN HEALTHCARE PROFESSIONAL REPORTED THAT IN A STUDY, AFTER INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE STUDY PATIENT EXPERIENCED AN INABILITY TO SEE WELL POSTOPERATIVELY WITH THE LENSES. THE IOLS WERE REMOVED DURING THE SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS NOT REQUESTED DUE TO LACK OF REPORTER CONTACT INFORMATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR 2ND EYE.
Patient problems: Visual Impairment
MAUDE report 15500713 ↗InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH VISION AND DIPLOPIA. POST SURGERY, THE PATIENT EXPERIENCED CORNEAL EDEMA AND VISION WAS GETTING WORSE OVER TIME. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THE PATIENT ISSUE HAS BEEN RESOLVED AND THE LENS WAS EXCHANGED FOR A NON COMPANY LENS. NO FURTHER INFORMATION AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Blurred Vision; Corneal Edema; Visual Disturbances
MAUDE report 15453383 ↗InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CERTIFIED OPHTHALMIC ASSISTANT (HEALTH CARE PROFESSIONAL) FOLLOWING IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED DECREASED VISION (UNHAPPY WITH VISION) AND DIPLOPIA (DOUBLE VISION). POST SURGERY, THE PATIENT EXPERIENCED CORNEAL EDEMA AND VISION HAS BEEN GETTING WORSE OVER TIME. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH NON COMPANY IOL. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Corneal Edema; Visual Impairment
MAUDE report 15427480 ↗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 ↗InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED IN A CLINICAL STUDY THAT DURING THE STUDY PATIENT NEVER COMPLAINED OF HALOS, HOWEVER AFTER THE TRIAL WAS COMPLETED NOTED THAT THE PATIENT HAD EXPERIENCED HALOS IN THE LEFT EYE. THE LENS WAS THEN EXCHANGED IN A SECONDARY PROCEDURE WITHOUT ANY COMPLICATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Halo
MAUDE report 14618587 ↗MalfunctionFeb 17, 2022Break; Break
A PHYSICIAN VIA CLINICAL STUDY REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS BROKEN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13549923 ↗InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD VISUAL DISTURBANCES. DIFFRACTIVE IOL WAS CAUSING GLARE AND HALO. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS WITHIN 7 MONTHS AFTER INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Halo; Visual Disturbances
MAUDE report 12984643 ↗MalfunctionJul 12, 2021Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A SCRATCH WAS NOTICED ON THE LENS. THE LENS WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12149288 ↗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 ↗InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED EXPLANTED INTRAOCULAR LENS, WITH A REASON OF UNDESIRED VISUAL QUALITY AND MONOCULAR DIPLOPIA. POST IMPLANTATION AFTER ONE YEAR SIX MONTHS THE LENS WAS REPLACED WITH OTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 12110197 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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