ACRYSOF® SN60WF (REF SN60WF.230)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 aspherical intraocular lens is a foldable implant used to replace the eye's natural lens during cataract surgery. The 42 reports mostly describe the lens's flexible arms (haptics) breaking, cracking, or bending during handling, loading, or implantation, sometimes before the lens reached the patient, along with some reports of contamination or unclear details. Nine reports involved injuries and no deaths were reported. 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
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00380655093252), received between Mar 30, 2021 and Aug 28, 2026 — classified as 9 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Break” (9 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
- Break9
- Device Contamination with Chemical or Other Material6
- Adverse Event Without Identified Device or Use Problem4
- Material Twisted/Bent4
- Crack3
- Material Split, Cut or Torn3
- Defective Device2
- Failure to Deliver2
Patient problems
- Insufficient Information16
- No Clinical Signs, Symptoms or Conditions16
- Blurred Vision4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Capsular Bag Tear2
- Corneal Edema2
- Visual Impairment2
- Eye Pain1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 50493654 ↗MalfunctionMar 13, 2026Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION CRACK NOTICED POST-IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24590977 ↗MalfunctionFeb 10, 2026Material Twisted/Bent
A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT LENS WAS NOT IMPLANTED BECAUSE ONE HAPTIC WAS DEFECTIVE, LENS DID NOT TOUCH THE PATIENT'S EYE AND THE DEVICE WAS NOT SAVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24305708 ↗MalfunctionJan 28, 2026Break
A COMPLAINT WAS RECEIVED FROM THE (B)(6) SYSTEM REGARDING A PATIENT WHO UNDERWENT INTRAOCULAR LENS IMPLANTATION IN HIS LEFT EYE ON (B)(6) 2025. DURING THE PROCEDURE THE HAPTIC OF THE INTRAOCULAR LENS (IOL) BROKE DURING DELIVERING. THE BROKEN IOL WAS REMOVED, AND A NEW IOL WAS IMPLANTED. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24199565 ↗MalfunctionJan 7, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE ONE OF THE LENS HAPTIC WAS BROKEN DURING HANDLING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23988114 ↗MalfunctionNov 26, 2025Break; Break
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT DURING THE SURGERY, HAPTIC DAMAGE WAS NOTICED IN THE LENS, AND THEREFORE THE LENS WAS REPLACED WITH COMPANY LENS.
Patient problems: Insufficient Information
MAUDE report 23656093 ↗MalfunctionNov 14, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TWO OF THE HAPTICS BROKE WHILE LOADING LENS INTO THE CARTRIDGE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION RECEIVED CONFIRMING THAT HAPTIC BROKEN WAS TRAILING HAPTIC FOR BOTH LENSES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23551856 ↗MalfunctionNov 11, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TWO OF THE HAPTICS BROKE WHILE LOADING LENS INTO THE CARTDRIGE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION RECEIVED STATING THAT TRAILING HAPTIC BROKE WHILE LOADING INTO THE CARTDRIGE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH REPORT. THIS IS 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522934 ↗MalfunctionOct 15, 2025Material Discolored; Material Discolored
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A YELLOWISH FILM COVERING THE RIGHT LENS HAS DEVELOPED RESULTING IN EXCESSIVE GLARE AND BLURRINESS WITH DIMINISHED COLOR INTENSITY. THE PRODUCT HAS BEEN EFFECTIVE UNTIL SIX MONTHS AGO. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 23276419 ↗MalfunctionSep 9, 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, THAT THE LENS WAS STUCK IN CARTRIDGE AND HAPTIC WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23004459 ↗MalfunctionJul 21, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DAMAGED BY THE INTRODUCER. LENS WAS THEN REMOVED FROM THE INTRODUCER AND A UNSPECIFIED BACKUP LENS WAS USED. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22555411 ↗MalfunctionJun 16, 2025Material Discolored; Material Discolored
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE SURGERY AFTER OPENING IOL (INTRA OCULAR LENS) COVER AND WHEN TRIED TO WASH IT BECAME DISCOLORED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22211843 ↗MalfunctionDec 27, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NURSE REPORTED BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE TRAILING HAPTIC IS THE ONE STUCK TO THE ANTERIOR SURFACE OF THE OPTIC. SURGEON HAD TO USE 2 INSTRUMENTS AND A CONSIDERABLE AMOUNT OF EFFORT TO GET THE HAPTIC OFF THE OPTIC WITH NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS PATIENT CONTACT, BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026933 ↗MalfunctionJul 24, 2024Break; Break
A PHYSICIAN STATED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19816625 ↗MalfunctionMay 20, 2024Product Quality Problem; Material Twisted/Bent; Product Quality Problem; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING SURGERY, THEY NOTICED THAT ONE HAPTIC WAS FOUND TWISTED AND BENT OVER THE OPTIC PART AND THE OPTIC PART WAS HAVING SOME BUBBLES IN THE STRUCTURE. SURGERY WAS COMPLETED WITH ANOTHER IOL. THE MAIN INCISION WAS ENLARGED TO 2.75, THE IOL CUT IN 2 WITH FORCEPS, AN NEW IOL IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19351148 ↗InjuryMar 1, 2024Break; Break
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, THE HAPTIC BROKE CAUSING THE CHAMBER RUPTURE. VITRECTOMY PROCEDURE WAS PERFORMED AND THE PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Capsular Bag Tear
MAUDE report 18814975 ↗MalfunctionJan 17, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS COULD NOT BE USED DUE TO TECHNICAL FAILURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT DURING THE INSERTION OF LENS THE SURGEON OBSERVED A BREAK ON LENS. THE LENS WAS REMOVED AND REPLACED WITH NEW LENS DURING INITIAL PROCEDURE. THE SYMPTOMS WERE RESOLVED AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18524839 ↗InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT A DAY AFTER INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, VISION IN HIS RIGHT EYE WAS NOT AS GOOD AS COMPARED TO LEFT EYE WHICH WAS PREVIOUSLY OPERATED. THE PATIENT INFORMED THE PHYSICIAN ABOUT IT AND THE PHYSICIAN PRESCRIBED CERTAIN EYE DROPS TO BE CONTINUED FOR NEXT 3 MONTHS AND TO COME AGAIN FOR CONSULTATION. SINCE THE LAST 13 MONTHS, PATIENTS HAVE VISITED PHYSICIAN NUMBER OF TIMES AND PHYSICIAN SUGGESTED NEW EYE DROPS. THE PATIENT HAS OBSERVED THAT AFTER AN OPERATION ON HIS RIGHT EYE HE GET PAIN WHILE TOUCHING HIS EYELID. THE VISION OF HIS RIGHT EYE IS NOT CLEAR AS COMPARED TO HIS LEFT EYE, AND FELT LIKE SOMETHING WAS STUCK IN HIS EYE. THE PATIENT WANTED TO KNOW IF THERE IS A PROBLEM WITH LENSES WHICH THE PHYSICIAN FITTED IN THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE PATIENT HAD REDNESS AND HEAVINESS IN EYES.
Patient problems: Blurred Vision; Eye Pain; Foreign Body Sensation in Eye; Red Eye(s)
MAUDE report 18481096 ↗MalfunctionJan 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING SURGERY, THEY NOTICED A CENTRAL FRACTURE. THERE WAS NO PATIENT HARM. THE PROCEDURE COMPLETED THE SAME DAY, AFTER IT WAS DELAYED FOR 10 MINUTES. SYMPTOMS HAS BEEN RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18452377 ↗InjuryAug 11, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT HAS BEEN UNDER ANTI-INFLAMMATORY MEDICAL TREATMENT SINCE THE MANIPULATION REQUIRED TO REMOVE THE BROKEN LENS CAUSED SEVERE CORNEAL EDEMA WHICH IS NOT RESOLVED YET.
Patient problems: Corneal Edema
MAUDE report 17509375 ↗MalfunctionMay 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CORRECT LOADING OF THE LENS WAS CARRIED OUT, HOWEVER WHEN ENTERING THE EYE IT WAS TORN IN THE CENTER OF THE OPTICS. THE PHYSICIAN REMOVED THE LENS WITH GOOD MANAGEMENT. THE PROCEDURE WAS COMPLETED WITH BACK UP LENS. THE PATIENT WAS DOING WELL AND THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17008695 ↗OtherMay 22, 2023Activation Problem
MalfunctionMay 22, 2023Crack; Crack
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF CRACK IN OPTIC CENTRALLY. THE PATIENT CONTACT WAS NOTED. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16972505 ↗MalfunctionMar 14, 2023Failure to Eject; Failure to Eject
ADDITIONAL INFORMATION RECEIVED AND STATED THAT INSERTION ERROR WAS DUE TO TECHNICIAN ERROR.
Patient problems: Insufficient Information
MAUDE report 16535341 ↗MalfunctionFeb 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BLUE OR WHITE THREADS STUCK TO THE IOL. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS REPORT IS FOR THREE OF FOUR.
Patient problems: Insufficient Information
MAUDE report 16334941 ↗
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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