ACRYSOF® SN60WF (REF SN60WF.215)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 artificial lens implanted during cataract surgery. The 46 reports mostly describe the lens breaking or tearing during handling and implantation — often at its small arms — so it would not come out of its cartridge or had to be removed and replaced, along with some scratched material and a few reports of inflammation or vision loss. 13 reports describe injuries, with no deaths. No recalls name this device. Reports fell from 9 to 2 in the past 12 months.
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
- 46
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00380655093221), received between Mar 18, 2021 and May 25, 2026 — classified as 13 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Break” (7 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 Problem7
- Break7
- Defective Device6
- Scratched Material4
- Inaccurate Delivery3
- Material Split, Cut or Torn3
- Appropriate Device Problem Term/Code Not Available2
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Insufficient Information14
- Capsular Bag Tear3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Hypopyon2
- Inflammation2
- Visual Impairment2
- Blurred Vision1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, WHEN THE LENS WAS PLACED AND BEFORE ROTATING IT WITH THE ROTATOR, THE HAPTIC BECAME LOOSE. THE LENS WAS SUBSEQUENTLY REMOVED IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25271190 ↗MalfunctionMar 3, 2026Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, LENS WAS IMPLANTED, BUT IT WAS DAMAGED SO IT WAS REMOVED AGAIN. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24494488 ↗InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DEVELOPED CORNEAL INFILTRATION, HYPOPYON AND INFLAMMATION. THERE IS A LOSS OF VISION AFTER ONE MONTH. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Corneal Infiltrates; Hypopyon; Inflammation; Loss of Vision
MAUDE report 22993772 ↗MalfunctionAug 28, 2025Break; Product Quality Problem; Break; Product Quality Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR WHEN TRYING TO LOAD THE LENS INTO THE CARTRIDGE, IT FEELS VERY RIGID, AND WHEN TRYING TO GRASP THE HAPTICS WAS IMMEDIATELY FRACTURED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS WITH SIMILAR CHARACTERISTICS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912270 ↗MalfunctionAug 13, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING LENS LOADING, THE LENS FAILED TO EXIT THE CARTRIDGE, INDICATING A DEFECT. THE PRODUCT WAS REPLACED WITH A NEW ONE, AND THE SURGERY WAS SAFELY COMPLETED WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22791511 ↗MalfunctionAug 7, 2025Break; Break
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS HAPTIC WAS BROKEN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22740161 ↗InjuryMay 28, 2025Product Quality Problem; Failure to Unfold or Unwrap; Device Damaged by Another Device; Product Quality Problem; Failure to Unfold or Unwrap; Device Damaged by Another Device
A CHINESE HEALTH AUTHORITY REPORTED THAT, DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL BECAME STUCK AND WHEN ATTEMPTING TO REMOVE IT, THE LENS WAS DAMAGED. THE REPORTER SUSPECTS THAT THE QUALITY OF THE PRODUCT MATERIAL MAY BE THE CAUSE OF THIS ISSUE. ADDITIONALLY, THE PATIENT EXPERIENCED MINIMAL IRIS BLEEDING AND POSTERIOR CAPSULE RUPTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: Capsular Bag Tear; Hyphema
MAUDE report 22096500 ↗MalfunctionMay 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED IOL WAS BROKEN. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002702 ↗MalfunctionApr 18, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS SCRATCHED, WHEN THE COMPANY INJECTOR WAS ADVANCED. INJECTOR WENT UNDER THE LENS INSTEAD OF PUSHING IT INSIDE THE EYE. THERE WAS NO PATIENT HARM. NEW UNSPECIFIED SPARE LENS WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21865702 ↗MalfunctionFeb 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF WHEN LOADING THE INTRAOCULAR LENS INTO THE INJECTOR THE SURGEON NOTICED THAT THE APEX OF THE LENS HAD CRACKS VISIBLE UNDER A MICROSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21363839 ↗MalfunctionDec 5, 2024Defective Component; Defective Component
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED IN INITIAL PROCEDURE DUE BROKEN HAPTIC. THE LENS WAS REPLACED WITH MULTIPIECE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20856804 ↗MalfunctionAug 29, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL OPTIC IS FULL OF IN GLISTENING DEPOSITS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20101704 ↗InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATING THAT THE DOCTOR DID NOT EXPECT THAT THE ROOTCAUSE WOULD BE THE COMPANY PRODUCT.
Patient problems: Eye Pain; Fibrosis; Hypopyon; Inflammation; Uveitis; Visual Impairment; Vitritis
MAUDE report 18768208 ↗MalfunctionFeb 22, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS DAMAGED DURING THE SURGERY. THE SURGERY WAS COMPLETED USING STANDBY LENSES. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 18756856 ↗MalfunctionJan 1, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, AFTER IMPLANTING THE LENS IN THE PATIENT'S EYE, THE SURGEON FOUND A STRAIGHT LINE FROM LEFT TO RIGHT ACROSS THE LENS. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18423148 ↗MalfunctionDec 26, 2023Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY WHEN THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S EYE, A SMALL PART OF THE LENS BROKE OFF. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PARTICLE WITHOUT DAMAGE TO THE LENS OR THE PATIENT. THE BROKEN PARTICLE APPEARED TO BE A TRANSPARENT PIECE OF PLASTIC ABOUT 1-2 MM IN LENGTH AND 1 MM WIDE. THE IOL WAS SUCCESSFULLY IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE
Patient problems: Insufficient Information
MAUDE report 18391943 ↗InjuryDec 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A CONSUMER REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE PATIENT SEES PURPLE FROM THAT EYE. IN 2020 HE WAS TOLD THE CATARACT HAD COME BACK. HE STATES NOW HE WAS TOLD THE LENS WAS CROOKED AND THE PHYSICIAN LET THE FLUID GET OUT OF THE EYE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Photophobia
MAUDE report 18343272 ↗MalfunctionJun 29, 2023Difficult to Insert; Failure to Unfold or Unwrap; Difficult to Insert; Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL DID NOT INSERT PROPERLY. THE LENS WAS EXPLANTED IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATED THAT THE LENS DID NOT INSERT PROPERLY IN INSERTER AND IT DID NOT FOLD OUT CORRECTLY.
Patient problems: Insufficient Information
MAUDE report 17225160 ↗MalfunctionJun 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS HAD TO BE LADED MULTIPLE TIMES AS IT WAS UNABLE O BE INSERTED. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17070730 ↗MalfunctionJun 6, 2023Defective Device; Defective Device
A NURSE REPORTED THAT, DURING SURGERY, WHEN THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, A PHYSICIAN NOTICED A SMALL CIRCULAR DEFECT (CIRCULAR BUBBLE) IN THE LENS. PHYSICIAN TRIED TO REMOVED (THE CIRCULAR BUBBLE) BY IRRIGATING AND ASPIRATING WITH IRRIGATION AND ASPIRATION (I&A) EQUIPMENT IN SAME PROCEDURE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17070022 ↗MalfunctionApr 21, 2023Defective Device; Defective Device
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED PERIPHERAL OPTIC ZONE WAVY THREAD LIKE PATTERN LINES OVER THE IMPLANTED IQ INTRAOCULAR LENS. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THE LENS WAS IMPLANTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16785282 ↗MalfunctionApr 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
AN OT NURSE REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS TORN DURING IMPLANTATION PROCEDURE. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16762598 ↗InjuryMar 15, 2023Crack; Crack
ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE LENS WAS STILL REMAINS IMPLANTED IN THE PATIENTS EYE.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 16545181 ↗MalfunctionDec 22, 2022Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE SURGEON NOTICED THERE WAS A SCRATCH ON THE LENS. THE LENS WAS CUT AND REMOVED OUT OF EYE. A BACK UP LENS WAS USED, PATIENT DID NOT NEED MEDICAL ATTENTION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16033215 ↗MalfunctionDec 5, 2022Failure to Fold; Failure to Advance; Failure to Fold; Failure to Advance
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IT WAS FOUND THAT FAILURE TO DEPLOY LENS WAS FOLDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15914386 ↗
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- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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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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