ACRYSOF IQ RESTORRecalls & reported problems across all models
Alcon Laboratories, Inc. · 34 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls
- 0
We found 34 models of ACRYSOF IQ RESTOR by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Mar 1, 2021 and Jun 5, 2025 — classified as 41 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 reports).
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 IQ RESTOR problems
Device problems
- Adverse Event Without Identified Device or Use Problem33
- Device Dislodged or Dislocated6
- Material Opacification3
- Defective Device2
- Malposition of Device2
- Scratched Material2
Patient problems
- Blurred Vision20
- Visual Disturbances15
- Visual Impairment13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Halo5
- Insufficient Information3
- Eye Pain2
- Posterior Capsule Opacification2
ACRYSOF IQ RESTOR models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR5 reports
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR3 reports
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR2 reports
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR2 reports
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR2 reports
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR2 reports
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR2 reports
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR2 reports
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR2 reports
- ACRYSOF, IQ RESTOR SND1T3LENS, MULTIFOCAL INTRAOCULAR2 reports
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD1LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF, IQ RESTOR SND1T4LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF, IQ RESTOR SND1T4LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF, IQ RESTOR SND1T4LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF, IQ RESTOR SND1T5LENS, MULTIFOCAL INTRAOCULAR1 report
- AcrySof® IQ ReSTOR® SV25T3LENS, MULTIFOCAL INTRAOCULAR1 report
- AcrySof® IQ ReSTOR® SV25T3LENS, MULTIFOCAL INTRAOCULAR1 report
- AcrySof® IQ ReSTOR® SV25T3LENS, MULTIFOCAL INTRAOCULAR1 report
- AcrySof® IQ ReSTOR® SV25T5LENS, MULTIFOCAL INTRAOCULAR1 report
- ACRYSOF® IQ RESTOR® SN6AD3LENS, MULTIFOCAL INTRAOCULAR1 report
Recent ACRYSOF IQ RESTOR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT LENS WAS MOVING AROUND AND CAUSING BLURRY VISION. IT WAS MENTIONED THAT CONSUMER WAS GOING TO GET THE IMPLANT REMOVED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED VISION WAS BLURRED, WENT TO SEE RETINA SPECIALIST. LENS WAS DISLOCATED. SCHEDULED FOR SURGERY NEXT WITH RETINA SPECIALIST. CONSUMER WILL HAVE MONOFOCAL LENS REPLACEMENT. NO HISTORY OF HEAD INJURY OR EYE INJURY. UNKNOWN CAUSE FOR DISLOCATION. HAS BEEN TOLD HE HAS A VERY LARGE EYE.
Patient problems: Blurred Vision
MAUDE report 22150911 ↗MalfunctionDec 5, 2024Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, DAMAGED INTRA OCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20855576 ↗InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER WHO HAD UNDERGONE INTRAOCULAR LENS (IOL) IMPLANTATION ON 01/16/2008 IN RIGHT EYE, REPORTED THAT HE HAD BEEN EXPERIENCING BLURRED VISION IN RIGHT EYE FOR LAST TWO MONTHS. HE STATED THAT HE HAD SEEN HIS OPHTHALMOLOGIST WHO DID NOT PROVIDE ANY REASON FOR THE BLURRED VISION, BUT TOLD IT WAS TOO RISKY TO REMOVE THE LENS. HE HAD UNDERGONE LASIK PROCEDURE AND YAG (YTTRIUM-ALUMINUM-GARNET LASER) ON (B)(6) 2018. ACCORDING TO THE PATIENT RECORD FROM (B)(6) 2018, ALMOST THREE MONTHS AFTER YAG, HE STATED THAT HE WAS NOT REALLY NOTICING ANY IMPROVEMENT AND WAS STILL SEEING FILM OVER HIS RIGHT EYE. HIS VISION WAS BLURRY AND FUZZY. ACCORDING TO THE PATIENT RECORD FROM (B)(6) 2021, HIS DISTANCE VISION WAS GETTING FOGGY, BUT NEAR VISUAL ACUITY WAS GOOD.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 20238481 ↗InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL VIA A REGULATORY AGENCY REPORTED THAT A PATIENT HAD BILATERAL IMPLANTATION OF INTRAOCULAR LENS. IN JUNE 2016, DUE TO OPACIFICATION, THE PATIENT HAD TO UNDERGO VITRECTOMY AND YAG LASER TREATMENT. SINCE THE PREVIOUS AUGUST, CLOUDINESS HAD REOCCURRED IN THE PATIENT¿S EYES AND HAD BEEN WORSENING. THE PATIENT¿S OPTOMETRIST DIAGNOSED THE EARLY DEVELOPMENT OF CATARACTS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Posterior Capsule Opacification
MAUDE report 20096146 ↗InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL VIA A REGULATORY AGENCY REPORTED THAT A PATIENT HAD BILATERAL IMPLANTATION OF INTRAOCULAR LENS. IN (B)(6) 2016, DUE TO OPACIFICATION, THE PATIENT HAD TO UNDERGO VITRECTOMY AND YAG LASER TREATMENT. IT WAS FURTHER REPORTED ABOUT CLOUDINESS HAD REOCCURRED IN THE PATIENT¿S EYES AND HAD BEEN WORSENING. THE PATIENT¿S OPTOMETRIST DIAGNOSED THE EARLY DEVELOPMENT OF CATARACTS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Posterior Capsule Opacification
MAUDE report 20083529 ↗MalfunctionApr 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
A CONSUMER REPORTED ABOUT A LENS FLOATS AROUND IN THE LENS CHAMBER WHICH WAS IMPLANTED 16 YEARS AGO. WHEN HE ANGLE THE LENS, CAN SEE THAT THE 2 HAPTICS OF THE LENSES, WHICH WERE SUPPOSED TO HOLD THEM IN POSITION, WERE COMPLETELY FLAT AGAINST THE LENS. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19125242 ↗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 ↗InjuryNov 6, 2023Adverse 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 DETACHED RETINA IN ONE OF THE EYE. THE EYE DOCTOR SUGGESTED LASER CORRECTION. THE PATIENT WISHES TO SEE WITHOUT GLASSES AND HAD NO OTHER ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Retinal Detachment; Visual Impairment
MAUDE report 18072492 ↗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 ↗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 LEFT EYE.
Patient problems: Blurred Vision
MAUDE report 17150871 ↗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 ↗InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN OPHTHALMOLOGIST REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD DIFFICULTY NIGHT DRIVING. MULTIFOCAL INTOLERANCE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. NO PATIENT HARM. PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT SURGEON DID PARS PLANA VITRECTOMY IN ADDITION TO IOL EXCHANGE.
Patient problems: Visual Disturbances
MAUDE report 15869527 ↗InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE THE PATIENT COMPLAINS OF TROUBLE NIGHT DRIVING AND GLARE. THE IOL WAS EXCHANGED WITH ANOTHER IOL. THE PATIENT ISSUE HAS BEEN RESOLVED. THERE WAS NO PATIENT HARM AND NO HOSPITALIZATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 15678965 ↗InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DOUBLE VISION, UNHAPPY WITH QUALITY OF VISION AND REFRACTIVE OUTCOME. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT HARM AND THE PATIENT WAS NOT HOSPITALIZED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 15650676 ↗InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT FEELS TIRED. THE PHYSICIAN SUGGESTED TO USE DROPS TO HELP LUBRICANT MY EYES BUT THE TIREDNESS PERSIST CONTINUES AND THERE HAS BEEN NO IMPROVEMENT ALL THIS TIME. THE PATIENT WAS TRIED ALL KINDS OF LUBRICATING DROPS BUT NO IMPROVEMENT. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, FELLS MORE TIRED MORE AT HOME. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Eye Pain
MAUDE report 15377156 ↗
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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