ACRYSOF® SN60WF (REF SN60WF.250)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
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00380655093290), received between Mar 23, 2021 and May 15, 2026 — classified as 3 injuries, 19 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Scratched Material3
- Device Damaged by Another Device2
- Failure to Fold2
- Failure to Unfold or Unwrap2
- Material Deformation2
- Material Split, Cut or Torn2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information10
- Eye Injury1
- Fibrosis1
- Posterior Capsule Opacification1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2026Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION, GLISTENING OF LENS WAS OBSERVED IN THE PATIENT AFTER THE SURGERY. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; Posterior Capsule Opacification
MAUDE report 25186085 ↗MalfunctionMar 31, 2026Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY AFTER FULLY OPENING THEN LENS AND IMPLANTATION SURGEON NOTICED A SLIGHT BLEMISH IN THE VISUAL AXIS OF THE LENS. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE. SURGERY WAS COMPLETED ON THE SAME DAY BY OPENING THE NEW LENS OF THE SAME DIOPTER WITHOUT ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24740580 ↗MalfunctionJan 13, 2026Scratched Material
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR NOTICED A MARK ON THE LENS. SO, DECIDED AGAINST IMPLANTING IT AND IMPLANTED ANOTHER UNSPECIFIED LENS. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24051653 ↗MalfunctionNov 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT SURGERY WAS COMPLETED WITH THE COMPANY LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23655089 ↗MalfunctionJul 28, 2025Material Discolored; Material Opacification; Material Discolored; Material Opacification
A HEALTH CARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT REPORTED OPACIFIED LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22629419 ↗MalfunctionMay 6, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE NOTICED THAT ONE OF THE HAPTIC OF THE LENS WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED LENS ON SAME DAY WITHOUT ANY HARM TO THE PATIENT AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT THE ISSUE IS WITH THE LEADING HAPTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21966636 ↗MalfunctionMar 7, 2025Product Quality Problem; Product Quality Problem
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF FAULTY LENS, NOT IMPLANTED. ADDITIONAL INFORMATION RECEIVED STATING THAT BUBBLE WAS SEEN ON THE OPTIC OF THE IOL UPON OPENING. SURGEON CHOSE NOT TO IMPLANT THIS IOL DUE TO THE IMPERFECTION. THE PROCEDURE WAS COMPLETED BY USING UNSPECIFIED REPLACEMENT IOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21545628 ↗MalfunctionFeb 26, 2024Material Deformation; Material Deformation
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: No Clinical Signs, Symptoms or Conditions
MAUDE report 18777588 ↗InjuryJan 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT TWO YEARS AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED LECOG/POSSIBLE PHIMOSIS IN THE EYES. THE SURGEON PERFORMED POSTERIOR AND ANTERIOR YTTRIUM-ALUMINUM-GARNET LASER (YAG) CAPSULOTOMIES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Fibrosis
MAUDE report 18423161 ↗MalfunctionAug 11, 2023Break; Break
A PHYSICIAN REPORTED A BROKEN LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17509408 ↗MalfunctionAug 7, 2023Failure to Fold; Device Damaged by Another Device; Failure to Fold; Device Damaged by Another Device
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE LENS WAS DAMAGED EVEN WHEN PUSHED INTO THE INJECTOR SLEEVE ITSELF, DESPITE CAREFUL AND SLOW INJECTION. THERE WAS FOLDING ISSUE OF LENS. THE PROCEDURE WAS ABLE TO COMPLETED BY USING ANOTHER LENS.
Patient problems: Insufficient Information
MAUDE report 17477466 ↗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 15779160 ↗MalfunctionJun 9, 2022Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE TIME OF IMPLANTING LENS IN THE CARTRIDGE AND ASSEMBLING IT IN THE AUTO SEARCH THE LENS GOT STUCK AND GOT SCRATCHED. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT PROCEDURE WAS COMPLETED SAME DAY AND THERE WAS A PATIENT CONTACT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 14642701 ↗MalfunctionMay 24, 2022Failure to Advance; Scratched Material; Failure to Advance; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED VIA IOL REPLY CARD, DURING INTRAOCULAR LENS IMPLANT PROCEDURE, LENS WAS NOT INSERTED IN EYE DUE TO DIFFICULTY WITH INSERTION AND SCRATCH ON LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14487416 ↗MalfunctionJan 28, 2022Defective Device; Device Contamination with Chemical or Other Material; Defective Device; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE OPTIC WAS FOUND TO BE CONVEX AND THERE WAS SOME FOREIGN BODY (MORE LIKE SERRATED) ON IT WHEN VIEWING THE VIDEO AFTER THE IOL WAS IMPLANTED INTO THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13379959 ↗MalfunctionNov 25, 2021Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE BENT. THE LENS WAS WASTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12874258 ↗MalfunctionNov 7, 2021Contamination; Contamination
A PHYSICIAN REPORTED AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION THE LENS HAD FEW WHITE AND BLACK SPOTS ON THE OPTIC. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12759410 ↗MalfunctionSep 20, 2021Failure to Fold; Failure to Unfold or Unwrap; Appropriate Device Problem Term/Code Not Available; Failure to Fold; Failure to Unfold or Unwrap; Appropriate Device Problem Term/Code Not Available
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL HAS LOADING ISSUES AND IOL FOLDED OVER WITH PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Insufficient Information
MAUDE report 12494613 ↗InjuryAug 25, 2021Entrapment of Device; Material Split, Cut or Torn; Entrapment of Device; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS GOT TRAPPED IN THE INCISION DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL). THE SURGEON ADVANCED THE LENS AND NOTICED A FRACTURE IN THE OPTICS. THE INCISION WAS WIDENED. THE IOL WAS REMOVED AND DISCARDED. A BACK UP LENS WAS IMPLANTED WITHOUT HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Eye Injury
MAUDE report 12364715 ↗MalfunctionJul 21, 2021Crack; Crack
A PHYSICIAN REPORTED THAT AN INTRAOCULAR LENS (IOL) CRACKED DURING IMPLANTATION. THE IOL WAS EXPLANTED AND REPLACED WITH THE SAME MODEL AND DIOPTER DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE DAMAGED IOL WAS REMOVED WITHOUT FURTHER COMPLICATIONS. POST OPERATION THE HEALTH STATUS OF PATIENT WAS GOOD WITHOUT ANY COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12202482 ↗MalfunctionJul 15, 2021Break; Break
A NON HEALTH CARE PROFESSIONAL REPORTED THAT, BROKEN LENS AND WASTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12175872 ↗MalfunctionMar 23, 2021Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOTED TO BE BROKEN AT TIME OF IMPLANTATION. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11553253 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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