ACRYSOF® SN60WF (REF SN60WF.190)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 intraocular lens is placed in the eye during cataract surgery. Reports mostly describe lenses tearing, cracking or turning cloudy while being loaded or injected, with surgery then finished using another lens. There are 24 reports that mention this identifier, including no deaths and 8 injuries, and 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
- 24
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00380655093177), received between Apr 19, 2021 and Sep 12, 2025 — classified as 8 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Break” (4 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 Problem4
- Break4
- Crack2
- Defective Device2
- Difficult to Advance2
- Failure to Advance2
- Failure to Unfold or Unwrap2
- Material Discolored2
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information6
- Blurred Vision2
- Capsular Bag Tear2
- Visual Disturbances2
- Discomfort1
- Eye Injury1
- Visual Impairment1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Break; Break
THE HEALTH CARE PROFESSIONAL STATED THAT DURING CATARACT SURGERY WHEN THE LENS INSERTING INTO CARTRIDGE, FOUND THAT TRAILING HAPTIC WAS TORN AND LENS DID NOT INJECT INTO THE PATIENT¿S EYE, AND THE SURGERY WAS COMPLETED BY USING ANOTHER LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23036773 ↗MalfunctionJun 13, 2025Failure to Deliver; Material Split, Cut or Torn; Failure to Deliver; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS BECAME STUCK IN THE INJECTOR AND SUBSEQUENTLY TORE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22204352 ↗MalfunctionMar 5, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC OF LENS WAS TORN. THE SURGERY COMPLETED WITH THE REPLACEMENT LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21526304 ↗MalfunctionDec 31, 2024Crack; Crack
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS CRACKED UNABLE TO USE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21046378 ↗MalfunctionOct 30, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SEEN FRACTURED AT THE CORNER OF THE HELIX AT THE TIME OF IMPLANTATION. THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570300 ↗MalfunctionOct 23, 2024Material Discolored; Material Opacification; Material Discolored; Material Opacification
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS IMPLANT PROCEDURE THE SURGEON NOTICED THE LENS OPACITY (TURN CLOUDY), THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20513181 ↗MalfunctionAug 1, 2023Crack; Material Twisted/Bent; Crack; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION PROCEDURE, A 1-2 MM LINEAR BLACK APPEARING DEFECT WAS OBSERVED IN THE CENTER OF OPTIC, WHICH LOOKED LIKE A CRACK UNDERNEATH WHERE THE END OF THE HAPTIC WAS PLACED ON TO THE OPTIC, AS THE IMPRESSION OF END OF HAPTIC APPEARED OVER/SURROUNDING THE DEFECT. LEADING HAPTIC WAS ALSO TWISTED, BUT THIS WAS NOT ASSOCIATED WITH DAMAGE. THE LENS WAS REMOVED AND REPLACED IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 17435614 ↗InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT AN INTRAOCULAR LENS WAS INSERTED AND REMOVED DURING THE INITIAL PROCEDURE DUE TO SAC RIPPED. THE SURGERY WAS COMPLETED WITH AN ANTERIOR LENS.
Patient problems: Capsular Bag Tear
MAUDE report 16961748 ↗MalfunctionApr 4, 2023Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS GOT STRUCK IN INJECTOR.
Patient problems: Insufficient Information
MAUDE report 16677199 ↗MalfunctionJan 17, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IMPLANT DID NOT UNFOLD DURING A SURGERY. THE PROCEDURE WAS COMPLETED WITH BACKUP LENS. THERE WAS NO IMPACT ON THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16183209 ↗MalfunctionNov 11, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT UNFOLD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15779099 ↗MalfunctionSep 20, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, FOREIGN BODY WAS NOTICED ON THE OPTIC, WHICH WAS QUITE ADHERED TO THE OPTIC AND WAS NOT ABLE TO BE ASPIRATED SO SURGEON LEFT THE LENS INSIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15453217 ↗MalfunctionSep 8, 2022Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED VIA IMPLANT CARD THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS DAMAGED. THE LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15378813 ↗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 RIGHT EYE.
Patient problems: Discomfort
MAUDE report 15130303 ↗MalfunctionJul 12, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REQUESTED AN NORMAL IOL AND THE PACKAGE WAS CONFIRMED OF THE CORRECT POWER. WHEN INJECTED THE IOL AND AS IT WAS UNFOLDING PHYSICIAN AMAZED TO SEE THE USUAL TORIC IOL MARKS ON THE OPTIC. THE PHYSICIAN EXPLANTED THE IOL AND REPLACED IT WITH ANOTHER NORMAL LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING SURGICAL INTERVENTION REQUIRED AS A RESULT OF EVENT WAS IOL EXTRACTION AND REPLACEMENT AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH PROGRAM STATING THE SURGERY PERFORMED WAS LEFT EYE CATARACT EXTRACTION SURGERY AND INTRAOCULAR LENS (IOL) IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14989019 ↗MalfunctionMay 27, 2022Defective Device; Defective Device
A FACILITY REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE, LENS HAD A BUBBLY LINE FROM THE FRONT HAPTIC TO THE CENTER OF THE LENS. DOCTOR IMPLANTED THE LENS AND IT STAYED IN THE PATIENTS EYE. HE STATED IT WOULD NOT AFFECT HIS VISION. ADDITIONAL INFORMATION WAS RECEIVED THAT, THERE WAS NO HARM TO THE PATIENT. THE PATIENT WAS NOT HOSPITALIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14520674 ↗InjuryMay 15, 2022Material Discolored; Material Discolored
A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT WAS WELL UNTIL 2020 WHEN SHE HAD A RIGHT VITREOUS HEMORRHAGE OF UNCERTAIN ORIGIN WHICH RESOLVED COMPLETELY WITH NO LOSS OF VISION. SHE HAS NOT HAD YAG CAPSULOTOMIES. VA HAS REMAINED BETWEEN 6/6 TO 6/9. THE PATIENT HAD COMPLAINED OF BLURRING OF VISION. ON EXAMINATION OF HER IOLS THROUGH THE DILATED PUPIL IT WAS EVIDENT THAT THE LENS WAS VERY MUCH YELLOWER PARTICULARLY THE BACK SURFACE OF THE LENS WHERE THE SHEET OF YELLOW WAS PRESENT. NEW GLASSES WOULD BE MADE WHICH IMPROVES VISION TO 6/7.5. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Vitreous Hemorrhage
MAUDE report 14403975 ↗InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED VIA IOL ( INTRAOCULAR LENS) REPLY CARD THAT, IOL WAS INSERTED AND REMOVED DURING THE INITIAL PROCEDURE. THE SURGEON HAD TO INSERT THE IOL IN ANTERIOR CHAMBER. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, DURING THE SURGERY, THE POSTERIOR CAPSULE WAS COMPROMISED AND FOUND THAT INSERTED IOL FOUND TO BE UNSTABLE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE PATIENT HARM WAS UNKNOWN
Patient problems: Capsular Bag Tear
MAUDE report 14139897 ↗InjuryFeb 15, 2022Material Opacification; Material Opacification
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WORSENING VISION. AFTER EXAMINATION, IOL OPACIFICATION IN THE LEFT EYE WAS DETECTED AND YAG (YTTRIUM ALUMINUM GARNET) LASER CAPSULOTOMY WAS INDICATED. HOWEVER, THE LENS OPACIFICATION WAS NOT ALTERED EVEN AFTER THE PROCEDURE WAS PERFORMED, THUS MAINTAINING THE PATIENT'S COMPLAINT.
Patient problems: Visual Disturbances
MAUDE report 13534545 ↗MalfunctionFeb 9, 2022Particulates; Appropriate Device Problem Term/Code Not Available; Particulates; Appropriate Device Problem Term/Code Not Available
A SURGEON REPORTED THAT FOLLOWING POST-OPERATIVE DAY ONE OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED WHITE PARTICLES ON THE IMPLANTED LENS AND GLISTENING. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13495742 ↗InjuryDec 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN OPHTHALMIC ASSISTANT REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL GOT DISLOCATED IN PATIENT'S EYE. HER VISION BECAME CLOUDY, BLURRY. SHE HAS VISUAL OBSCURATIONS AND ABERRATIONS, DECREASED VISION WITH A PERIPHERAL ARC IN HER VISION FROM LIGHT COMING FROM THE SIDE IN PARTICULAR AND DECREASED VISION RELATIVE TO WHAT SHE HAD. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. NO INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 13109550 ↗InjuryJun 14, 2021Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANTATION PROCEDURE THERE WAS DIFFICULTY ADVANCING LENS INTO EYE, SURGEON WIDENED INCISION. THERE WAS NO PATIENT HARM.
Patient problems: Eye Injury
MAUDE report 11992930 ↗MalfunctionMay 24, 2021Difficult to Advance; Difficult to Advance
A FACILITY REPRESENTATIVE REPORTED AN "ADVANCING ISSUE" DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11869140 ↗InjuryApr 19, 2021Break; Failure to Advance; Malposition of Device; Break; Failure to Advance; Malposition of Device
A SURGEON REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE REMOVAL OF THE CATARACT WAS COMPLETED UNEVENTFULLY. HOWEVER, WHEN IT CAME TIME TO INJECT THE LENS INTO THE BAG, THE HAPTIC WAS AMPUTATED OFF THE OPTIC. THEY DO NOT KNOW THE REASON FOR THIS, BUT IT COULD HAVE BEEN DUE TO A MISLOADED LENS OR DUE TO THE FACT THAT THE IOL WAS SITTING IN THE CARTRIDGE FOR A LONG PERIOD OF TIME. THE TECH IS AN EXPERIENCED ONE AND INSISTED THAT SHE LOADED THE LENS CORRECTLY. THE IOL WAS SLIGHTLY DECENTERED AT THE END OF THE CASE AND SHE ELECTED TO OBSERVE AS THE PATIENT IS MONOCULAR AND THIS IS HIS ONLY GOOD EYE. HOWEVER, POST OP DAY 1, HIS LENS WAS FURTHER DECENTERED. THE PATIENT IS DOING WELL NOW AFTER REQUIRING A SECOND SURGERY BY A RETINAL SPECIALIST TO REMOVE THE DEFECTIVE LENS AND REPLACE IT. ADDITIONAL INFORMATION OF PATIENT IDENTIFIERS, ASSOCIATED PRODUCTS, AND RELEVANT TEST DATA WAS PROVIDED. INFORMATION THAT THE SURGICAL TECH REPORTED THAT THE IOL LOADED WITHOUT ISSUE, BUT WHEN THE SURGEON TOOK THE LOADED LENS INJECTOR, SHE STATED IT WAS HARD TO PUSH, SO SHE ASKED THE SURGICAL TECH FOR FORCEPS. THE SURGEON USED THE FORCEPS TO HELP THE IOL OUT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11685533 ↗
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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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