ACRYSOF® SN60WF (REF SN60WF.235)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) IQ ASPHERIC Natural IOL, SINGLE-PIECE ACRYLIC FOLDABLE PCL, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS. · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon AcrySof IQ aspheric intraocular lens is a foldable lens implanted in the eye during cataract surgery. Most of the 42 reports describe the lens or its haptics (the small arms) cracking, breaking, twisting, or tearing during implantation surgery, sometimes forcing the surgeon to remove it and use another lens; a few mention blurry or cloudy vision afterward. There were 10 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00380655093269), received between Mar 23, 2021 and Feb 5, 2026 — classified as 10 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Crack” (8 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, 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
- Crack8
- Adverse Event Without Identified Device or Use Problem5
- Break5
- Material Twisted/Bent5
- Device Contamination with Chemical or Other Material4
- Scratched Material4
- Failure to Advance3
- Defective Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Insufficient Information10
- Visual Impairment4
- Blurred Vision3
- Capsular Bag Tear2
- UGH (Uveitis Glaucoma Hyphema) Syndrome2
- Visual Disturbances2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2026Break
A PHYSICIAN REPORTED WITH A DESCRIPTION OF ONE OF THE INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24269289 ↗MalfunctionDec 30, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WITH NO END. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23923014 ↗MalfunctionAug 6, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE AT THE TIME OF INSERTION THE IOL, ITS HAPTIC REMAINED ATTACHED IN THE OPTIC BODY AND AFTER MANY MANIPULATIONS OF THE SURGEON, THE HAPTIC DID NOT EXPANDED. AFTER THAT, THE SURGEON FORCED TO REMOVE THE IOL FROM THE PATIENT EYE DURING THE INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22725859 ↗MalfunctionJun 30, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHEN PREPARING THE IOL IN THE INJECTOR, THE HAPTIC PRESENTED AN INADEQUATE FOLD, DESPITE SEVERAL ATTEMPTS. WHEN ATTEMPTING TO INSERT THE IOL, THE INJECTOR PLUNGER DID NOT PROPEL IT, AND IMPLANTATION WAS NOT POSSIBLE. THE SURGERY WAS COMPLETED WITH ANOTHER UNSPECIFIED LENS ON THE SAME DAY USING THE SAME INJECTOR AND CARTRIDGE. THERE WAS NO PATIENT HARM AND NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22355752 ↗MalfunctionApr 24, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED DURING CATARACT INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING THE INTRODUCTION OF THE IOL INTO THE CAPSULE, THE FINAL LOOP DID NOT PROGRESS EVEN THOUGH COMPLETED THE ENTIRE INJECTION· THE IOL HAS ALREADY EXITED THE INJECTOR WITH THE HANDLE DIRECTED· SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED STATING THAT HAPTIC DID NOT PROGRESS EVEN THOUGH THE ENTIRE INJECTOR WAS FINISHED. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898429 ↗InjuryApr 23, 2025Material Deformation; Material Deformation
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MISTING AND CLOUDINESS OF HIS VISION DESPITE NO OTHER ISSUES. UP TO DATE REFRACTION WITH LEFT EYE WAS 6/7.5 AND WAS WORSE. THERE WERE GLISTENING BUT MAINLY SURFACE CALCIFICATION, LEFT EYE GREATER THAN RIGHT EYE. THE PATIENT ALSO HAD YAG LASER PROCEDURE (YTTRIUM ALUMINUM GARNET) IN THE POSTERIOR CHAMBER. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE LES WAS PLANNED TO BE EXPLANTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 21891732 ↗InjuryApr 23, 2025Material Deformation; Material Deformation
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MISTING AND CLOUDINESS OF HIS VISION DESPITE NO OTHER ISSUES. UP TO DATE REFRACTION WITH RIGHT EYE WAS 6/6 AND FOR THE LEFT EYE 6/7.5, WORSE IN THE LEFT EYE. THERE WERE GLISTENING BUT MAINLY SURFACE CALCIFICATION, LEFT EYE GREATER THAN RIGHT EYE. THE PATIENT ALSO HAD YAG LASER PROCEDURE (YTTRIUM ALUMINUM GARNET) IN THE POSTERIOR CHAMBER. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE LES WAS PLANNED TO BE EXPLANTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 21890840 ↗MalfunctionApr 17, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS TORN ON BOTH SIDES OF THE OPTIC. NOTICED AFTER IMPLANTATION. IOL WAS IMMEDIATELY REMOVED DURING THE INITIAL PROCEDURE AND A NEW LENS IMPLANTED. SCRUB NURSE DID NOT SEE ANY DAMAGE PRIOR TO THE IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO ADVERSE EFFECTS FOR THE PATIENT. SURGERY WAS COMPLETED USING THE BACKUP LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21854961 ↗MalfunctionMar 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED WITH A DESCRIPTION, AT THE TIME OF INTRAOCULAR LENS (IOL) INSPECTION IN CARTRIDGE IT WAS NOTICED THAT THERE WAS A CRACK IN THE OPTIC OF IOL. DOCTOR BELIEVES THAT IT WAS CREATED FROM A DEFECTIVE CARTRIDGE. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21633960 ↗MalfunctionFeb 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS CRACK/TEAR WITHIN THE LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED WHEN THE LENS WAS PLACED IN THE PATIENT EYE IT APPEARED AS THOUGH THERE WAS A FIBER OR HAIR BEHIND THE LENS. AFTER MULTIPLE ATTEMPTS TO REMOVE THE FOREIGN OBJECT IT WAS DETERMINED THAT THE DEFECT WAS IN THE LENS ITSELF, POSSIBLY A CRACK IN THE LENS. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21469079 ↗MalfunctionJan 27, 2025Crack; Crack
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON FOUND CRACK ON THE OPTIC OF THE LENS.
Patient problems: Insufficient Information
MAUDE report 21239967 ↗MalfunctionJan 22, 2025Break; Failure to Advance; Break; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STUCK WITH PLUNGER, DOCTOR PULLED OUT AND CAUSED HAPTIC BROKEN. EXPLANTED THE FAULTY LENS AND IMPLANTED WITH UNSPECIFIED BACKUP LENS WITHOUT COMPLICATION. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED LENS WAS EXPLANTED FROM THE DEVICE NOT FROM THE EYE.
Patient problems: Insufficient Information
MAUDE report 21207164 ↗MalfunctionNov 14, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEPLOYED PRIOR TO IMPLANTATION INTO THE ANTERIOR CHAMBER. THE SURGERY WAS COMPLETED WITH BACKUP LENS.
Patient problems: Insufficient Information
MAUDE report 20685517 ↗MalfunctionNov 13, 2024Break; Break
A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, INTRAOCULAR LENS (IOL) WAS SEEN BROKEN IN THE CARTRIDGE AND WAS NOT IMPLANTED. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER IOL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20675159 ↗InjuryJun 4, 2024Material Twisted/Bent; Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, POSTERIOR CAPSULE RUPTURED WHEN ROTATING THE LENS, SURGEON SUSPECTS HAPTIC EDGE DEFECT CAUSED THIS INCIDENT. A BACKUP SULCUS LENS USED AS REPLACEMENT. THE PROCEDURE COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 19458163 ↗InjuryDec 29, 2023Crack; Unintended Ejection; Scratched Material; Failure to Eject; Crack; Unintended Ejection; Scratched Material; Failure to Eject
A OTHER HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS REMOVED FROM THE WAGON WHEEL AND PLACED IN CARTRIDGE. THE IOL WAS FINE WHEN REMOVED FROM THE WAGON WHEEL. AFTER IMPLANTATION SCRATCHES / CRACKS WERE FOUND ON THE LENS. IOL WAS EXPLANTED AND REPLACED WITH NEW IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear; Insufficient Information; Zonular Dehiscence
MAUDE report 18417477 ↗MalfunctionOct 4, 2023Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTING THE LENS, SOME MARKS ON THE IMPLANTED LENS ARE VERIFIED UNDER THE MICROSCOPE, WHICH ACCORDING TO THE DOCTOR SHOULD NOT AFFECT THE PATIENT'S VISION.ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17866769 ↗MalfunctionSep 25, 2023Material Opacification; Material Opacification
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IN THE POSTOPERATIVE EXAMINATION, PIGMENTATION WAS DETECTED ON THE SURFACE OF THE LENS WHEN VIEWED UNDER A SLIT LAMP. THE PATIENT EXPERIENCED POOR VISUAL QUALITY FOLLOWING THE SURGICAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 17809589 ↗MalfunctionFeb 16, 2023Defective Device; Defective Device
A PHARMACY ASSISTANT REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PHYSICIAN VERIFIED THAT THE LENS WAS DAMAGED. THERE WAS A CONTACT WITH THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER IOL. THERE WAS NO PATIENT HARM AND SYMPTOMS. THE PATIENT WAS NOT HOSPITALIZED AND THERE WAS NO MEDICAL INTERVENTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16385092 ↗InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS NO LONGER THE SAME AND EXPERIENCED DRY EYE. THE OPTOMETRIST PRESCRIBED THE EYE DROPS AS HER EYE WAS VERY DRY. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Dry Eye(s); Visual Impairment
MAUDE report 16377527 ↗MalfunctionDec 28, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE GLISTENINGS WAS NOTICED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16062811 ↗MalfunctionDec 19, 2022Crack; Crack
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAD A CRACK OR LINE THROUGH IT, WHICH WAS DESCRIBED AS DAMAGED AND HAD TO BE EXPLANTED. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16003954 ↗MalfunctionDec 6, 2022Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL UNFOLDS INCORRECTLY, LEAVING THE PROXIMAL HAPTIC STRETCHED AND BREAKING THE HAPTIC, HOWEVER THE LENS REMAINS INSIDE THE ANTERIOR CHAMBER, THE LENS WAS CUT AND REMOVED FROM THE EYE. ANOTHER LENS WITH THE SAME POWER WAS IMPLANTED DURING INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 15923745 ↗InjuryDec 3, 2022Adverse 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 LENS WAS EXPLANTED FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT EXPERIENCING UVEITIS GLAUCOMA/UGH SYNDROME/HYPHEMA, INCREASE IOP, TRANSILLUMINATION, NASAL IRIS ATROPHY AND VITREOUS HEMORRHAGE. THE PARACENTESIS PERFORMED. IN THE SURGEON¿S OPINION, PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT ITS UGH SYNDROME CAUSED THE EVENTS. THE PATIENT'S ISSUES RESOLVED WERE RESOLVED. THE LENS WAS EXPLANTED AND REPLACED WITH NON COMPANY LENS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Decreased; UGH (Uveitis Glaucoma Hyphema) Syndrome; Visual Disturbances; Vitreous Hemorrhage
MAUDE report 15912117 ↗MalfunctionNov 5, 2022Crack; Crack
A GOVERNMENT AGENCY REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TWO CRACKS WERE FOUND IN THE LENS UNDER THE MICROSCOPE. THE INTRA OCULAR LENS WAS CUT OFF AND REMOVED AND NEW LENS WAS REPLACED SAME DAY. THE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15740939 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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.
How reports and recalls are matched · Editorial policy · Report an error on this page