ACRYSOF® SN60WF (REF SN60WF.220)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 SN60WF is a foldable plastic intraocular lens implanted in the eye during cataract surgery. Its 37 reports mostly describe the lens breaking, twisting or bending during implantation, failing to unfold when the surgeon injected it, or getting stuck in the cartridge, so the surgery often had to be finished with a different lens. 29 malfunctions and 8 injuries were reported, with 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
- 36
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00380655093238), received between May 21, 2021 and Mar 10, 2026 — classified as 8 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Break” (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, 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
- Break6
- Failure to Unfold or Unwrap5
- Material Twisted/Bent4
- Adverse Event Without Identified Device or Use Problem3
- Crack3
- Defective Device3
- Failure to Deliver3
- Failure to Eject3
Patient problems
- Insufficient Information18
- No Clinical Signs, Symptoms or Conditions10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Visual Disturbances2
- Visual Impairment2
- Anxiety1
- Blurred Vision1
- Corneal Clouding/Hazing1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Material Deformation
A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, DAMAGE ON THE LENS WAS NOTICED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND THE PROCEDURE COMPLETED ON THE SAME DAY. NO FURTHER INFORMATION IS EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24557830 ↗MalfunctionJan 30, 2026Break
A NURSE REPORTED AN UNKNOWN LENS ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS DAMAGE TO THE IMPLANT DURING INSERTION INTO THE LENS CAPSULE, HAPTIC AMPUTATION. THERE WAS PATIENT CONTACT. PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24220842 ↗MalfunctionJan 8, 2026Break
A CONSUMER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHILE LOADING THE LENS SURGEON OBSERVED THAT ONE HAPTIC WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PROCEDURE WAS FINISHED BY IMPLANTING ANOTHER LENS.
Patient problems: Insufficient Information
MAUDE report 24003716 ↗MalfunctionDec 30, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IENS WAS PUT INSIDE CARTRIDGE AND THE INJECTOR GOING INSIDE THE EYE, THE LENS WAS NOT MOVING FORWARD, AND IT GOT STUCK INTO THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23924061 ↗MalfunctionOct 24, 2025Material Discolored; Device Difficult to Setup or Prepare; Material Discolored; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT LENS COLOR WAS SLIGHTLY DIFFERENT FROM ROUTINE LENS AND THE BEHAVIOR WHILE LOADING WAS ALSO VERY DIFFERENT AND FELT RIGID THAN ROUTINE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23381500 ↗MalfunctionSep 18, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS NOT WORKING. THE LENS WAS REMOVED IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23082045 ↗MalfunctionAug 19, 2025Break; Failure to Deliver; Material Twisted/Bent; Break; Failure to Deliver; Material Twisted/Bent
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE HAPTIC WAS DEFORMED OR HAPTIC ABNORMALLY EXTENDED THE SURGEON WAS NOT CONFIDENT IN USING ON PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE TRAILING HAPTIC WAS STUCK, WHILE RETRACT INJECTOR AND PULLING THE LENS OUT THE HAPTIC WAS TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22839202 ↗MalfunctionAug 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON NOTICED THAT THE LENS HAD A STRANGE U-SHAPED DEFECT ON THE OPTIC AFTER THE LENS WAS INSERTED INTO THE EYE. THE LENS WAS CUT AND REMOVED FROM THE EYE, THEN REPLACED WITH ANOTHER DIFFERENT 22.0 DIOPTER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY FURTHER CONSEQUENCES FOR THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 22783801 ↗MalfunctionJun 25, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION HAPTIC LOOKED TWISTED AND WAS NOT ABLE TO RECOVER BACK. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER IOL.
Patient problems: Insufficient Information
MAUDE report 22330166 ↗MalfunctionJun 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS LOADED AS USUAL WITH NO ISSUES NOTED BY EXPERIENCED STAFF. THE LENS CARTRIDGE WAS INSERTED INTO THE INJECTOR AND ENGAGED WITH NO PROBLEMS OR STIFFNESS. THE SURGEON PLACED THE LENS INTO THE EYE WITH NO RESISTANCE. ONCE INSIDE THE EYE, THE LENS WAS FOUND TO BE CRACKED. THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE, REPLACED WITHOUT ISSUE, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 22204110 ↗MalfunctionMay 26, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN INSERTING A LENS USING A CARTRIDGE AND INJECTOR, THE LOWER HAPTIC WAS OBSERVED TO PROTRUDE. THE OPTIC AND UPPER HAPTIC ARE TRAPPED IN THE INJECTOR WITH THE PLUNGER INSIDE THE ANTERIOR CHAMBER, ATTEMPTING TO LOWER THE HAPTIC. THE MANEUVER WAS PERFORMED WITHOUT SUCCESS. THE SECOND LENS WAS INSERTED WITHOUT COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084663 ↗MalfunctionNov 21, 2024Failure to Eject; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, FAILED TO ADVANCED AND NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20748023 ↗MalfunctionSep 24, 2024Failure to Eject; Failure to Eject
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WOULD NOT DEPLOY AND WAS NOT IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 20291170 ↗MalfunctionSep 24, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WOULD NOT UNFOLD AND WAS NOT IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 20291168 ↗MalfunctionJul 4, 2024Scratched Material; Failure to Eject; Scratched Material; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS DID NOT INSERT FULLY INTO MAIN INCISION. ON REMOVAL, IOL SCRATCHED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19675078 ↗MalfunctionJun 14, 2024Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SMALL PIECE OF THE LENS WAS MISSING. SURGERY WAS COMPLETED WITH THE BACK UP LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19535121 ↗MalfunctionJun 6, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS WAS DEFECTIVE, THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19476018 ↗MalfunctionMar 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE BROKEN WHEN IMPLANTING IN TO THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18928554 ↗MalfunctionFeb 14, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DAMAGED INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS DID NOT OPEN CORRECTLY IN THE EYE AND PROCEDURE WAS COMPLETED WITH NEW LENS DURING INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 18702543 ↗InjurySep 21, 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 EXPERIENCED SYMPTOMS OF DYSPHOTOPSIA , STARBURSTS , PERCEPTUAL DISTORTION , PELOPSIA. PATIENT EXPRESSED THE SYMPTOMS TO THE SURGEON AND SURGEON ADVISED TO WAIT TILL THE SYMPTOMS ADJUST. BUT THE SYMPTOMS WERE NOT DISAPPEARED AND HAD BECOME SEVERELY BOTHERSOME OVER TIME. THE PATIENT WAS EXPERIENCING ONGOING LOSS OF BALANCE AND DIZZINESS DUE TO THE CHRONIC PELOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE (OD).
Patient problems: Dizziness; Visual Disturbances
MAUDE report 17787178 ↗MalfunctionJun 26, 2023Material Opacification; Material Opacification
A CONSUMER REPORTED THAT FOLLOWING TWO YEARS OF CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS CLOUDED UP. THE CONSUMER HAD TRIED READERS OF ALL NUMBERS TO HELP WITH THIS, BUT NO HELP. THE CONSUMER'S RIGHT EYE WAS OKAY BUT OVERWORKING TO HELP THE LEFT ONE. THE CONSUMER LOVES TO READ, BUT IT IS NOW AN ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 17201755 ↗InjuryMay 16, 2023Scratched Material; Scratched Material
AN ADMINISTRATOR HAS REPORTED ABOUT THAT AFTER IMPLANTATION OF INTRAOCULAR LENS DURING THE INITIAL PROCEDURE, SCRATCH ON LENS WAS NOTED. THE LENS WAS CUT OUT BY ENLARGING THE INCISION AND SUTURE WAS PLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Injury
MAUDE report 16937341 ↗MalfunctionApr 12, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTH CARE PROFESSIONAL REPORTED THAT, THE INTRAOCULAR LENS HAS A DEFECT AND THE LENS COULD NOT BE UNFOLDED. ADDITIONAL INFORMATION RECEIVED AND CONFIRMED THAT, THERE WAS PATIENT CONTACT WITH THE DEVICE AND WAS IOL WAS REPLACED WITH NEW IOL.
Patient problems: Insufficient Information
MAUDE report 16721743 ↗InjuryMar 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DEVELOPED ENDOPHTHALMITIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Endophthalmitis
MAUDE report 16527282 ↗InjuryMar 7, 2023Component Missing; Component Missing
A PHYSICIAN REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS OBSERVED THAT ONE HAPTIC OF IOL WAS MISSING WHEN OPENED THE LENS PACKAGE. THE PATIENT WAS LEFT APHAKIC AND THE PROCEDURE WAS COMPLETED ON THE NEXT DAY. ADDITIONAL INFORMATION AS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16494257 ↗
Other intraocular lens devices
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- 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.
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