ACRYSOF® SN60WF (REF SN60WF.195)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 acrylic intraocular lens implanted in the eye during cataract surgery. The 26 reports mostly describe the lens breaking, cracking or tearing during loading or implantation, sometimes with blurred vision, irritation or a lens that had to be removed and replaced. There are 11 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
- 26
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00380655093184), received between Mar 11, 2021 and May 25, 2026 — classified as 11 injuries, 15 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
- Adverse Event Without Identified Device or Use Problem9
- Break6
- Defective Device2
- Device Damaged by Another Device2
- Material Split, Cut or Torn2
- Material Twisted/Bent2
- Appropriate Device Problem Term/Code Not Available1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information5
- Blurred Vision3
- Endophthalmitis2
- Visual Disturbances2
- Capsular Bag Tear1
- Discomfort1
- Dry Eye(s)1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT HAD BEEN UNABLE TO READ AND EXPERIENCED DRY EYES. THE PATIENT STATED THAT THEY HAD BEEN GOING BACK AND FORTH GETTING PLUGS INSERTED FOR DRY EYE MANAGEMENT, BUT CONTINUED TO EXPERIENCE SYMPTOMS, DESCRIBING A SENSATION AS IF A SHIELD CAME OVER THEIR EYES, PREVENTING THEM FROM READING MORE THAN ONE OR TWO PAGES. THEY REPORTED HAVING TRIED DIFFERENT PRESCRIPTION LENSES AND GLASSES WITHOUT RELIEF. THE PATIENT ALSO QUESTIONED WHETHER THERE HAD BEEN AN ISSUE WITH THE INTRAOCULAR LENS USED DURING THEIR CATARACT SURGERY IN 2021. THEY EXPRESSED SIGNIFICANT DISTRESS REGARDING THEIR VISION SINCE THE SURGERY AND INDICATED THAT THEY WERE PLANNING TO VISIT THEIR EYE DOCTOR THAT MORNING DUE TO ONGOING PROBLEMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.
Patient problems: Dry Eye(s)
MAUDE report 25271546 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT HAD A COMPLAINT OF FOREIGN BODY SENSATION. THE IMPLANTED LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Irritation
MAUDE report 24716590 ↗MalfunctionJan 8, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAPTIC WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003884 ↗MalfunctionJan 8, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING LOADING, THE INTRAOCULAR LENS (IOL) WAS FOUND TO BE FAULTY AND COULD NOT BE USED. THE REPORTER SPECIFICALLY NOTED THAT THE ISSUE WAS WITH THE LENS ITSELF, NOT THE HAPTIC. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003555 ↗MalfunctionNov 5, 2025Failure to Deliver; Device Damaged by Another Device; Failure to Deliver; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, WHILE LOADING THE LENS FAILED TO SLIDE SMOOTHLY INTO THE CARTRIDGE WHEN THE PLUNGER WAS ADVANCED. THIS LIKELY CAUSED MECHANICAL STRESS OR COMPRESSION ON THE OPTIC OR HAPTICS RESULTED IN DAMAGE. ADDITIONAL INFORMATION RECEIVED THAT THE DAMAGED LENS WAS NOT IMPLANTED AND THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23473611 ↗MalfunctionJul 17, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHEN THE IOL WAS BEING INSERTED THE HAPTIC STUCK IN BETWEEN PLUNGER AND HAPTIC WAS BROKEN. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS. THERE WAS A PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22530398 ↗MalfunctionJun 2, 2025Break; Optical Decentration; Break; Optical Decentration
A HEALTH CARE PROFESSIONAL DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED THAT THERE WAS NO TRAILING HAPTIC AND THE SURGEON LEFT THE IOL IN THE PATIENTS LENS BAG AND ROTATED THE IOL WITH ONLY HAPTIC INFERIORLY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE INTRAOCULAR LENS IS IN THE BAG AND DECENTRATION HAS OCCURRED WITH UNCORRECTED VISUAL ACUITY 6/12, SURGEON STATED THAT THE PATIENT PROBABLY NEEDS ANOTHER OPERATION TO EXPLANT THE LENS AND REPLACE IT .
Patient problems: Insufficient Information
MAUDE report 22125006 ↗MalfunctionFeb 5, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC TWISTED WHEN INSERTING INTO THE CARTRIDGE AND TORN WHEN PUSHING THE PLUNGER. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 21312056 ↗MalfunctionNov 13, 2024Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS OPTIC WAS BROKEN. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20672381 ↗InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING PATIENT EYE CANNOT BE SAVED OPERATED EYE WAS BLIND.
Patient problems: Endophthalmitis; Loss of Vision
MAUDE report 19124336 ↗MalfunctionAug 2, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS TORE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17440263 ↗MalfunctionJan 3, 2023Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS STUCK WITH THE INJECTOR PLUNGER AND CRACKED WHEN FURTHER ADVANCE. THE PHYSICIAN EXPLANTED AND COMPLETED THE PROCEDURE WITH BACKUP LENS WITHOUT ANY COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16086107 ↗MalfunctionNov 16, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A FLUFFY WHITE MATERIAL ASSOCIATED WITH THE LEADING HAPTIC AND LENS HAD TO BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15803119 ↗InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, HER EYES ARE STILL IRRITATING AND HAD TREATMENT FOR DRY EYE SYNDROME. PATIENT ALSO STATED THAT SHE HAS POLYCARB ALLERGY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Discomfort
MAUDE report 15129577 ↗InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT WAS UNABLE TO SEE AS SHE WISHED WITH THE RIGHT VISION SET FOR NEAR. THE LENS WAS EXPLANTED IN A SECONDARY SURGERY. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS FOR THE RIGHT EYE.
Patient problems: Blurred Vision
MAUDE report 14456069 ↗MalfunctionJan 31, 2022Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF CURLED INTRAOCULAR LENS (IOL). THE SURGERY WAS CANCELLED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13391494 ↗MalfunctionDec 22, 2021Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EYE TURNS RED WHEN EXPOSED TO SUNLIGHT AND AS A RESULT HIS DRIVING BECOME DANGEROUS. THE PATIENT THINKS HE MAY HAVE HAD SOME SORT OF LASER AT ONE TIME, BUT NOT SURE. THE PATIENT THINKS HIS LENSES ARE DETERIORATING AND NEEDED REPLACEMENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Red Eye(s)
MAUDE report 13059708 ↗MalfunctionDec 3, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A MEDICAL ENGINEER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND OTHER VISUAL SIDE EFFECTS. THE SLIT LAMP IMAGES AND THE PENTACAM IMAGES SHOW GLISTENING'S. DIAGNOSED WITH GLIMMER VISION, SPECIAL ON THE LEFT EYE. THE PATIENT ISSUE WAS NOT RESOLVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Visual Disturbances
MAUDE report 12927439 ↗InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BASED ON INFORMATION RECEIVED FOLLOWING SUBMISSION OF THE INITIAL REPORT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS A SERIOUS INJURY.
Patient problems: Blurred Vision
MAUDE report 12646249 ↗MalfunctionAug 2, 2021Break; Break
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD THAT AN INTRAOCULAR LENS (IOL) WAS WASTED, LENS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12263291 ↗InjuryJun 21, 2021Material Opacification; Material Opacification
A PHYSICIAN REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED 6 YEAR 5 MONTHS AFTER THE INITIAL PROCEDURE DUE TO THE OPACIFICATION IN THE LENS MATRIX. THE LENS WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12031260 ↗InjuryJun 1, 2021Malposition of Device; Malposition of Device
AN OPHTHALMIC ASSISTANT REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED DISLOCATED LENS AND NOTICED A CHANGE IN VISION 4 MONTHS AGO. IN SURGEON OPINION CAUSE OF EVENT IS PSEUDOPHAKODONESIS. THE LENS WAS REPOSITIONED IN THE EYE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 11915163 ↗InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED FOLLOWING THE INTRA OCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IMPLANTED IOL PARTIALLY FALL BACK DUE TO POSTERIOR CAPSULE OR THE ZONULES BROKE. THE IOL WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED. A QUESTIONNAIRE WAS RECEIVED.
Patient problems: Capsular Bag Tear; Zonular Dehiscence
MAUDE report 11864008 ↗InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED "ARCS OF LIGHT, GLARE, REFLECTIONS AND POSITIVE DYSPHOTPSIA." THE IOL WAS EXCHANGED APPROXIMATELY THREE MONTHS AFTER THE INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 11658223 ↗MalfunctionMar 12, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS SPLIT. THERE WAS CONTACT TO THE PATIENT BUT NO HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11478125 ↗
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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